<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767062</url>
  </required_header>
  <id_info>
    <org_study_id>2018/22-3</org_study_id>
    <nct_id>NCT03767062</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches</brief_title>
  <official_title>Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: In this study, the investigators compared the effectiveness of peripheral nerve&#xD;
      block (greater occipital nerve block with supratrochlear nerve block) versus topiramate as&#xD;
      detoxification therapies in chronic migraine patients with medication overuse headache.&#xD;
&#xD;
      Methods: At least ninety chronic migraine patients with medication overuse headache are aimed&#xD;
      to include in this study. Patients will be divided into the two groups. The first group will&#xD;
      receive topiramate (n=45, estimated) and the second group will receive nerve block (n=45,&#xD;
      estimated) as detoxification therapy. Patients' records regarding the visual analog scale&#xD;
      (VAS) scores and headache frequencies are aimed to be collected before and after the therapy.&#xD;
      Comparisons regarding VAS scores, headache frequencies, 50% responder rates and 75% responder&#xD;
      rates will be performed in between topiramate and nerve block groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>Post treatment (4 weeks later)</time_frame>
    <description>Range Pain 0-10, 0: No pain, 10: Worst Pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attack Frequencies</measure>
    <time_frame>Post treatment (4 weeks later)</time_frame>
    <description>Number of headaches patients suffer in a month.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Medication Overuse Headache</condition>
  <condition>Chronic Migraine, Headache</condition>
  <arm_group>
    <arm_group_label>Topiramate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Greater Occipital +Supratrochlear Nerve Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼&quot; (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topamax</intervention_name>
    <description>An antiepileptic agent used for migraine prophylaxis.</description>
    <arm_group_label>Topiramate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Greater Occipital Nerve Block + Supratrochlear Nerve Block</intervention_name>
    <description>An injection to paralyze the occipital and supratrochlear nerves.</description>
    <arm_group_label>Greater Occipital +Supratrochlear Nerve Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic migraine diagnosis according to International Classification of Headache-2&#xD;
             Disorders (ICHD)&#xD;
&#xD;
          2. w/o pregnancy or breastfeeding.&#xD;
&#xD;
          3. w/o acute or chronic psychiatric disorders.&#xD;
&#xD;
          4. w/o nephrolithiasis.&#xD;
&#xD;
          5. w/o medication of anticoagulant and antiaggregant.&#xD;
&#xD;
          6. w/o allergy to topiramate or bupivacaine.&#xD;
&#xD;
          7. w/o prophylaxis within the last three months with any of; propranolol, nebivolol,&#xD;
             topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.&#xD;
&#xD;
          8. w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.&#xD;
&#xD;
          9. w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor.&#xD;
&#xD;
        J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes,&#xD;
        pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lost to follow up within the pretreatment period during the detoxification therapy&#xD;
             after the detoxification therapy&#xD;
&#xD;
          2. could not tolerate the peripheral nerve block or topiramate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mustafa Ceylan</name>
      <address>
        <city>Erzurum</city>
        <zip>25000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Zwart JA, Dyb G, Hagen K, Svebak S, Holmen J. Analgesic use: a predictor of chronic pain and medication overuse headache: the Head-HUNT Study. Neurology. 2003 Jul 22;61(2):160-4. doi: 10.1212/01.wnl.0000069924.69078.8d.</citation>
    <PMID>12874392</PMID>
  </reference>
  <reference>
    <citation>Grazzi L, Andrasik F, D'Amico D, Usai S, Kass S, Bussone G. Disability in chronic migraine patients with medication overuse: treatment effects at 1-year follow-up. Headache. 2004 Jul-Aug;44(7):678-83. doi: 10.1111/j.1526-4610.2004.04127.x.</citation>
    <PMID>15209690</PMID>
  </reference>
  <reference>
    <citation>Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.</citation>
    <PMID>17300356</PMID>
  </reference>
  <reference>
    <citation>Tobin JA, Flitman SS. Occipital nerve blocks: effect of symptomatic medication: overuse and headache type on failure rate. Headache. 2009 Nov-Dec;49(10):1479-85. doi: 10.1111/j.1526-4610.2009.01549.x.</citation>
    <PMID>19912347</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <results_first_submitted>November 24, 2019</results_first_submitted>
  <results_first_submitted_qc>January 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2020</results_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk University</investigator_affiliation>
    <investigator_full_name>Mustafa Ceylan</investigator_full_name>
    <investigator_title>Principal İnvastigator</investigator_title>
  </responsible_party>
  <keyword>Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache Disorders, Secondary</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03767062/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Topiramate</title>
          <description>Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.&#xD;
Topamax: An antiepileptic agent used for migraine prophylaxis.</description>
        </group>
        <group group_id="P2">
          <title>Greater Occipital +Supratrochlear Nerve Block</title>
          <description>Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼&quot; (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.&#xD;
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Topiramate</title>
          <description>Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.&#xD;
Topamax: An antiepileptic agent used for migraine prophylaxis.</description>
        </group>
        <group group_id="B2">
          <title>Greater Occipital +Supratrochlear Nerve Block</title>
          <description>Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼&quot; (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.&#xD;
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.7" spread="7.1"/>
                    <measurement group_id="B2" value="32.9" spread="7.2"/>
                    <measurement group_id="B3" value="32.8" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale</title>
        <description>Range Pain 0-10, 0: No pain, 10: Worst Pain</description>
        <time_frame>Post treatment (4 weeks later)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.&#xD;
Topamax: An antiepileptic agent used for migraine prophylaxis.</description>
          </group>
          <group group_id="O2">
            <title>Greater Occipital +Supratrochlear Nerve Block</title>
            <description>Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼&quot; (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.&#xD;
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale</title>
          <description>Range Pain 0-10, 0: No pain, 10: Worst Pain</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="0.8"/>
                    <measurement group_id="O2" value="8.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post treatment (4 weeks later)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="1.2"/>
                    <measurement group_id="O2" value="5.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Attack Frequencies</title>
        <description>Number of headaches patients suffer in a month.</description>
        <time_frame>Post treatment (4 weeks later)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.&#xD;
Topamax: An antiepileptic agent used for migraine prophylaxis.</description>
          </group>
          <group group_id="O2">
            <title>Greater Occipital +Supratrochlear Nerve Block</title>
            <description>Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼&quot; (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.&#xD;
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.</description>
          </group>
        </group_list>
        <measure>
          <title>Attack Frequencies</title>
          <description>Number of headaches patients suffer in a month.</description>
          <units>headaches per month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" spread="3.1"/>
                    <measurement group_id="O2" value="20.9" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post treatment (4 weeks later)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.8"/>
                    <measurement group_id="O2" value="5.9" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Topiramate</title>
          <description>Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.&#xD;
Topamax: An antiepileptic agent used for migraine prophylaxis.</description>
        </group>
        <group group_id="E2">
          <title>Greater Occipital +Supratrochlear Nerve Block</title>
          <description>Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼&quot; (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.&#xD;
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Dizziness that affect concentration</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mustafa Ceylan</name_or_title>
      <organization>Ataturk University</organization>
      <phone>+905062773216</phone>
      <email>drmuson16@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767062
org study id: 2018/22-3
nct id: NCT03767062
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose: In this study, the investigators compared the effectiveness of peripheral nerve
      block (greater occipital nerve block with supratrochlear nerve block) versus topiramate as
      detoxification therapies in chronic migraine patients with medication overuse headache.

      Methods: At least ninety chronic migraine patients with medication overuse headache are aimed
      to include in this study. Patients will be divided into the two groups. The first group will
      receive topiramate (n=45, estimated) and the second group will receive nerve block (n=45,
      estimated) as detoxification therapy. Patients' records regarding the visual analog scale
      (VAS) scores and headache frequencies are aimed to be collected before and after the therapy.
      Comparisons regarding VAS scores, headache frequencies, 50% responder rates and 75% responder
      rates will be performed in between topiramate and nerve block groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analog Scale
time frame: Post treatment (4 weeks later)
description: Range Pain 0-10, 0: No pain, 10: Worst Pain
measure: Attack Frequencies
time frame: Post treatment (4 weeks later)
description: Number of headaches patients suffer in a month.
arm group label: Topiramate
arm group type: Active Comparator
description: Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
arm group label: Greater Occipital +Supratrochlear Nerve Block
arm group type: Active Comparator
description: Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
intervention type: Drug
intervention name: Topamax
description: An antiepileptic agent used for migraine prophylaxis.
arm group label: Topiramate
intervention type: Procedure
intervention name: Greater Occipital Nerve Block + Supratrochlear Nerve Block
description: An injection to paralyze the occipital and supratrochlear nerves.
arm group label: Greater Occipital +Supratrochlear Nerve Block
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
citation: Zwart JA, Dyb G, Hagen K, Svebak S, Holmen J. Analgesic use: a predictor of chronic pain and medication overuse headache: the Head-HUNT Study. Neurology. 2003 Jul 22;61(2):160-4. doi: 10.1212/01.wnl.0000069924.69078.8d.
PMID: 12874392
citation: Grazzi L, Andrasik F, D'Amico D, Usai S, Kass S, Bussone G. Disability in chronic migraine patients with medication overuse: treatment effects at 1-year follow-up. Headache. 2004 Jul-Aug;44(7):678-83. doi: 10.1111/j.1526-4610.2004.04127.x.
PMID: 15209690
citation: Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.
PMID: 17300356
citation: Tobin JA, Flitman SS. Occipital nerve blocks: effect of symptomatic medication: overuse and headache type on failure rate. Headache. 2009 Nov-Dec;49(10):1479-85. doi: 10.1111/j.1526-4610.2009.01549.x.
PMID: 19912347
responsible party type: Principal Investigator
investigator affiliation: Ataturk University
investigator full name: Mustafa Ceylan
investigator title: Principal İnvastigator
mesh term: Headache Disorders, Secondary
mesh term: Headache
mesh term: Topiramate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 