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NCT03275922 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
A Phase 3 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 374
- Enrollment target
NCT03275922: Completed Phase 3 study, sponsored by Impax Laboratories.
NCT03275922 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 374 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03275922, a Phase 3 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 374 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DRUG Placebo ZNS
- DRUG ZNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 3 |
What the finished NCT03275922 record still lists
NCT03275922 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo ZNS is the first listed.
NCT03275922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03275922 about?
NCT03275922 is a clinical study titled "Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE". 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 ...
What is the current status of trial NCT03275922?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 374 participants. The study started on 2017-11-27. Estimated completion is 2020-09-28.
What interventions are being tested in trial NCT03275922?
The interventions under investigation include: Placebo ZNS (DRUG), ZNS (DRUG).
Who is sponsoring clinical trial NCT03275922?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03275922's enrollment target sits among peer trials
374 991st of 2000 higher than 1,010 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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