<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/NCT03275922</url>
  </required_header>
  <id_info>
    <org_study_id>IPX229-B16-01</org_study_id>
    <nct_id>NCT03275922</nct_id>
  </id_info>
  <brief_title>Efficacy &amp; Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy And Safety Of Zolmitriptan Nasal Spray For The Treatment Of Acute Migraine In Subjects Ages 6 To 11 Years, With An Open-Label Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Impax Laboratories, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Impax Laboratories, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment&#xD;
      of migraine headache in subjects ages 6 to 11 years.&#xD;
&#xD;
      Part 1: Approximately 20 weeks (includes screening and double-blind treatment).&#xD;
&#xD;
        -  Screening will be performed based on the inclusion exclusion criteria specified in the&#xD;
           study protocol.&#xD;
&#xD;
        -  Randomize approximately 288 subjects into the double-blind crossover phase.&#xD;
&#xD;
      Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter&#xD;
      part 2, a 6 month open-label safety extension (OLE).&#xD;
&#xD;
      Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in&#xD;
      both the double-blind and the OLE.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">July 2, 2020</primary_completion_date>
  <phase>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>
    <intervention_model_description>A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain-free status at 2 hours post treatment</measure>
    <time_frame>2 hours post-dose</time_frame>
    <description>Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve pain-free status at 24 hours post-dose</measure>
    <time_frame>24 hours post-dose</time_frame>
    <description>The headache pain intensity is assessed by the subjects using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache response at 24 hours post-dose</measure>
    <time_frame>24 hours post-dose</time_frame>
    <description>The subject diary captures the headache severity using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0). Headache response is defined as a reduction in moderate (2) or severe (3) pain to mild (1) or no (0) pain at 24 hour post-dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained headache response at 24 hours post-dose</measure>
    <time_frame>24 hours post-dose</time_frame>
    <description>Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none at 2 hours which is then maintained (without a return to moderate or severe pain) at 24 hours with no use of rescue medication prior to the 24 hour assessment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">374</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Run-in - ZNS - Placebo - OLE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Run-in - Placebo - ZNS - OLE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo ZNS</intervention_name>
    <description>Placebo Zolmitriptan Nasal Spray</description>
    <arm_group_label>Run-in - Placebo - ZNS - OLE</arm_group_label>
    <arm_group_label>Run-in - ZNS - Placebo - OLE</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZNS</intervention_name>
    <description>Zolmitriptan Nasal Spray</description>
    <arm_group_label>Run-in - Placebo - ZNS - OLE</arm_group_label>
    <arm_group_label>Run-in - ZNS - Placebo - OLE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Parent or legal guardian is able to provide written informed consent and subject is&#xD;
             able to provide assent.&#xD;
&#xD;
          2. Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn&#xD;
             established diagnosis of migraine&#xD;
&#xD;
          3. By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3&#xD;
             hours per attack&#xD;
&#xD;
          4. By history, experiences at least 16 headache-free days per month on average&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of ischemic or vasospastic heart disease, arrhythmias associated with&#xD;
             accessory conduction pathways (eg, Wolff-Parkinson-White syndrome), cerebrovascular&#xD;
             disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic&#xD;
             bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another&#xD;
             5HT1 agonist, ergots or ergotamine-containing medications.&#xD;
&#xD;
          2. Any medical condition, including severe hepatic impairment, which, in the opinion of&#xD;
             the investigator, may put the subject at increased risk with exposure to zolmitriptan,&#xD;
             or may interfere with the safety or efficacy assessments.&#xD;
&#xD;
          3. Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist&#xD;
             drug (in the opinion of the investigator).&#xD;
&#xD;
          4. Had not experienced satisfactory relief from migraine pain during prior treatment with&#xD;
             2 or more adequate courses of triptans.&#xD;
&#xD;
          5. Prior use of any nasal spray (triptan or dihydroergotamine [DHE]) for the acute&#xD;
             treatment of migraine&#xD;
&#xD;
          6. Disease or anatomic abnormalities of the nasal cavity precluding or complicating the&#xD;
             use of ZNS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Impax Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Impax Laboratories, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children's Hospital (149)</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital (109)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Center, Inc (134)</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Medical Research (124)</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado (154)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Sky Neurology (106)</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMMUNOe Research Centers (150)</name>
      <address>
        <city>Thornton</city>
        <state>Colorado</state>
        <zip>80233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Health System (141)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NW Florida Clinical Research Group, LLC (122)</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc. (127)</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axcess Medical Research (126)</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biotech Pharmaceutical Group (138)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laszlo J. Mate, M.D., P.A. (153)</name>
      <address>
        <city>North Palm Beach</city>
        <state>Florida</state>
        <zip>33408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clincial Neuroscience Solutions, Inc. (136)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Neurology, PA (125)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Florida Research (143)</name>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34983</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pedatric Epilepsy &amp; Neurology Specialists (157)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute @ Palm Beach Neurology, PA (105)</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Integrative Research Center of Atlanta (121)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NuDirections Clinical Research, LLC (159)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta, LLC (146)</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC (130)</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Josephson Wallack Munshower Neurology P.C. (114)</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosair Charities Pediatric Clinical Research Unit (120)</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head-Pain and Neurological Institute (103)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Research (116)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of NJ (123)</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dent Neurosciences Research Center (129)</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OnSite Clinical Solutions, LLC (155)</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Headache Wellness Center (Site 152)</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Neurology Associates, PA (113)</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akron Children's Hospital (site 139)</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital (140)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Physicians, Inc. (115)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Access Clinical Trials, Inc. (151)</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Neurology, P.A. (110)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center Dallas (147)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research Inc. Foothill Family Clinic (107)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital Outpatient Services (117)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Granger Medical Holladay (111)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Research of Charlottesville, LLC (104)</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center (132)</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic (145)</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Headache</keyword>
  <keyword>Pain</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 2, 2021</submitted>
    <returned>July 23, 2021</returned>
  </pending_results>
  <!-- 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/NCT03275922
org study id: IPX229-B16-01
nct id: NCT03275922
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment
      of migraine headache in subjects ages 6 to 11 years.

      Part 1: Approximately 20 weeks (includes screening and double-blind treatment).

        -  Screening will be performed based on the inclusion exclusion criteria specified in the
           study protocol.

        -  Randomize approximately 288 subjects into the double-blind crossover phase.

      Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter
      part 2, a 6 month open-label safety extension (OLE).

      Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in
      both the double-blind and the OLE.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain-free status at 2 hours post treatment
time frame: 2 hours post-dose
description: Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
measure: Proportion of subjects who achieve pain-free status at 24 hours post-dose
time frame: 24 hours post-dose
description: The headache pain intensity is assessed by the subjects using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
measure: Headache response at 24 hours post-dose
time frame: 24 hours post-dose
description: The subject diary captures the headache severity using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0). Headache response is defined as a reduction in moderate (2) or severe (3) pain to mild (1) or no (0) pain at 24 hour post-dose.
measure: Sustained headache response at 24 hours post-dose
time frame: 24 hours post-dose
description: Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none at 2 hours which is then maintained (without a return to moderate or severe pain) at 24 hours with no use of rescue medication prior to the 24 hour assessment.
arm group label: Run-in - ZNS - Placebo - OLE
arm group type: Other
description: After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
arm group label: Run-in - Placebo - ZNS - OLE
arm group type: Other
description: After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
intervention type: Drug
intervention name: Placebo ZNS
description: Placebo Zolmitriptan Nasal Spray
arm group label: Run-in - Placebo - ZNS - OLE
arm group label: Run-in - ZNS - Placebo - OLE
other name: Placebo
intervention type: Drug
intervention name: ZNS
description: Zolmitriptan Nasal Spray
arm group label: Run-in - Placebo - ZNS - OLE
arm group label: Run-in - ZNS - Placebo - OLE
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Impax Study Director
role: Study Director
affiliation: Impax Laboratories, LLC
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country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
submitted: July 2, 2021
returned: July 23, 2021