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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 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 374 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03275922
The ClinicalTrials.gov registry entry for NCT03275922 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 374 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo ZNS is the first listed.
NCT03275922 reports 0 study locations.
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.
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