<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/NCT03022838</url>
  </required_header>
  <id_info>
    <org_study_id>2015/1729REK</org_study_id>
    <nct_id>NCT03022838</nct_id>
  </id_info>
  <brief_title>The Effects of Caffeine Withdrawal on Migraine</brief_title>
  <official_title>The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordlandssykehuset HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nordlandssykehuset HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sporadic and chronic dietary consumption of caffeine has substantial biological effects on&#xD;
      the nervous system. The effects on migraine are at large not known. In this study we want to&#xD;
      assess the effects of caffeine withdrawal on migraine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The actions of caffeine as an antagonist of adenosine receptors have been extensively&#xD;
      studied, and there is no doubt that both daily and sporadic dietary consumption of caffeine&#xD;
      has substantial biological effects on the nervous system. The current opinion is that&#xD;
      caffeine both can cure and trigger headaches. Caffeine is a component of many combination&#xD;
      drugs marketed for the relief of headaches, but on the other hand it is strongly incriminated&#xD;
      as a risk factor for developing chronic headache. Withdrawal may cause symptom constellations&#xD;
      similar to the migraine syndrome. Further, caffeine consumption may affect sleep and&#xD;
      alertness, possibly influencing the risk of migraine attacks. .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated prematurely due to poor recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 22, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Migraine days</measure>
    <time_frame>10 weeks</time_frame>
    <description>Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Withdrawal symptoms and/or syndrome (according to criteria)</measure>
    <time_frame>2 first days after caffeine withdrawal(withdrawal vs. caffeine)</time_frame>
    <description>If patients report withdrawal symptoms, these will be recorded and eventually diagnosed as either caffeine withdrawal symptoms or migraineous symptoms in accordance with international criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Migraine attacks</measure>
    <time_frame>10 weeks</time_frame>
    <description>Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep improvement</measure>
    <time_frame>10 weeks</time_frame>
    <description>Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>10 weeks</time_frame>
    <description>Reduction from baseline in HIT-6 (withdrawal vs. caffeine)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Migraine</condition>
  <condition>Caffeine Withdrawal</condition>
  <arm_group>
    <arm_group_label>Caffeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Caffeine tablets (Recip) 100 mg, 300-800 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caffeine</intervention_name>
    <description>From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).</description>
    <arm_group_label>Caffeine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Recip</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  migraine present for at least 1 year and fulfilling diagnostic criteria (ICHD-3 beta)&#xD;
&#xD;
          -  =/&gt; 3 migraine attacks per month&#xD;
&#xD;
          -  no migraine prophylaxis the last month&#xD;
&#xD;
          -  consumption =/&gt; 300 mg and &lt;/= 800 mg caffeine per day the last month&#xD;
&#xD;
          -  signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspicion of medication-overuse headache&#xD;
&#xD;
          -  pregnancy and breast feeding&#xD;
&#xD;
          -  serious co-morbidity or conditions requiring Medical treatment or caution&#xD;
&#xD;
          -  working night shift&#xD;
&#xD;
          -  use of drugs with moderate or major interactions with caffeine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan T Henriksen</last_name>
    <role>Study Director</role>
    <affiliation>Department for research and patient safety, Nordland Hospital trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nordland Hospital</name>
      <address>
        <city>Bodø</city>
        <zip>8011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departement of Neurology, NLSH HF</name>
      <address>
        <city>Bodø</city>
        <zip>8092</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departement of Neurology</name>
      <address>
        <city>Tromsø</city>
        <zip>9037</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03022838
org study id: 2015/1729REK
nct id: NCT03022838
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sporadic and chronic dietary consumption of caffeine has substantial biological effects on
      the nervous system. The effects on migraine are at large not known. In this study we want to
      assess the effects of caffeine withdrawal on migraine.
The actions of caffeine as an antagonist of adenosine receptors have been extensively
      studied, and there is no doubt that both daily and sporadic dietary consumption of caffeine
      has substantial biological effects on the nervous system. The current opinion is that
      caffeine both can cure and trigger headaches. Caffeine is a component of many combination
      drugs marketed for the relief of headaches, but on the other hand it is strongly incriminated
      as a risk factor for developing chronic headache. Withdrawal may cause symptom constellations
      similar to the migraine syndrome. Further, caffeine consumption may affect sleep and
      alertness, possibly influencing the risk of migraine attacks. .
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Migraine days
time frame: 10 weeks
description: Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)
measure: Withdrawal symptoms and/or syndrome (according to criteria)
time frame: 2 first days after caffeine withdrawal(withdrawal vs. caffeine)
description: If patients report withdrawal symptoms, these will be recorded and eventually diagnosed as either caffeine withdrawal symptoms or migraineous symptoms in accordance with international criteria
measure: Migraine attacks
time frame: 10 weeks
description: Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)
measure: Sleep improvement
time frame: 10 weeks
description: Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)
measure: Quality of life
time frame: 10 weeks
description: Reduction from baseline in HIT-6 (withdrawal vs. caffeine)
arm group label: Caffeine
arm group type: Active Comparator
description: Caffeine tablets (Recip) 100 mg, 300-800 mg
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets
intervention type: Drug
intervention name: Caffeine
description: From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
arm group label: Caffeine
arm group label: Placebo
other name: Recip
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jan T Henriksen
role: Study Director
affiliation: Department for research and patient safety, Nordland Hospital trust
facility: 
facility: 
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Caffeine
sharing ipd: No