Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
Public ClinicalTrials.gov record NCT03275922. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03275922
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 374 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2017 (Actual)
- Primary completion
- Jul 2, 2020 (Actual)
- Completion
- Sep 28, 2020 (Actual)
- Last update posted
- Jan 11, 2021
2017 – 2020
United States locations
- U.S. sites
- 47
- U.S. states
- 23
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital (149) | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital (109) | Little Rock | Arkansas | 72202 | — |
| Advanced Research Center, Inc (134) | Anaheim | California | 92805 | — |
| Sierra Medical Research (124) | Fresno | California | 17601 | — |
| Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119) | Sacramento | California | 95815 | — |
| Children's Hospital Colorado (154) | Aurora | Colorado | 80045 | — |
| Blue Sky Neurology (106) | Englewood | Colorado | 80113 | — |
| IMMUNOe Research Centers (150) | Thornton | Colorado | 80233 | — |
| Ki Health Partners, LLC dba New England INstitute for Clinical Research (128) | Stamford | Connecticut | 06905 | — |
| Children's National Health System (141) | Washington D.C. | District of Columbia | 20010 | — |
| NW Florida Clinical Research Group, LLC (122) | Gulf Breeze | Florida | 32561 | — |
| Clinical Neuroscience Solutions, Inc. (127) | Jacksonville | Florida | 32256 | — |
| Axcess Medical Research (126) | Loxahatchee Groves | Florida | 33470 | — |
| Biotech Pharmaceutical Group (138) | Miami | Florida | 33155 | — |
| Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142) | Miami | Florida | 33155 | — |
| Laszlo J. Mate, M.D., P.A. (153) | North Palm Beach | Florida | 33408 | — |
| Clincial Neuroscience Solutions, Inc. (136) | Orlando | Florida | 32801 | — |
| Pediatric Neurology, PA (125) | Orlando | Florida | 32819 | — |
| East Florida Research (143) | Port Saint Lucie | Florida | 34983 | — |
| Pedatric Epilepsy & Neurology Specialists (157) | Tampa | Florida | 17601 | — |
| Premiere Research Institute @ Palm Beach Neurology, PA (105) | West Palm Beach | Florida | 33407 | — |
| Clinical Integrative Research Center of Atlanta (121) | Atlanta | Georgia | 30328 | — |
| NuDirections Clinical Research, LLC (159) | Atlanta | Georgia | 30350 | — |
| iResearch Atlanta, LLC (146) | Decatur | Georgia | 30030 | — |
| Meridian Clinical Research, LLC (130) | Savannah | Georgia | 31406 | — |
| Josephson Wallack Munshower Neurology P.C. (114) | Indianapolis | Indiana | 46256 | — |
| Kosair Charities Pediatric Clinical Research Unit (120) | Louisville | Kentucky | 40202 | — |
| Michigan Head-Pain and Neurological Institute (103) | Ann Arbor | Michigan | 48104 | — |
| Mercy Research (116) | St Louis | Missouri | 63141 | — |
| Clinical Research Center of NJ (123) | Voorhees Township | New Jersey | 08043 | — |
| Dent Neurosciences Research Center (129) | Amherst | New York | 14226 | — |
| OnSite Clinical Solutions, LLC (155) | Charlotte | North Carolina | 28277 | — |
| Headache Wellness Center (Site 152) | Greensboro | North Carolina | 27405 | — |
| Raleigh Neurology Associates, PA (113) | Raleigh | North Carolina | 27607 | — |
| Akron Children's Hospital (site 139) | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital (140) | Cincinnati | Ohio | 45229 | — |
| Preferred Primary Care Physicians, Inc. (115) | Pittsburgh | Pennsylvania | 15236 | — |
| Access Clinical Trials, Inc. (151) | Nashville | Tennessee | 37203 | — |
| Texas Neurology, P.A. (110) | Dallas | Texas | 75214 | — |
| Children's Medical Center Dallas (147) | Dallas | Texas | 75235 | — |
| J. Lewis Research Inc. Foothill Family Clinic (107) | Salt Lake City | Utah | 84109 | — |
| Primary Children's Hospital Outpatient Services (117) | Salt Lake City | Utah | 84113 | — |
| Granger Medical Holladay (111) | Salt Lake City | Utah | 84117 | — |
| Pediatric Research of Charlottesville, LLC (104) | Charlottesville | Virginia | 22902 | — |
| Northwest Clinical Research Center (132) | Bellevue | Washington | 98007 | — |
| Multicare Health System- Mary Bridge Pediatrics- Tacoma (158) | Tacoma | Washington | 98405 | — |
| Marshfield Clinic (145) | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03275922, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03275922 live on ClinicalTrials.gov.