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NCT01667679 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
A Phase 3 study, sponsored by Avanir Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
NCT01667679: Completed Phase 3 study, sponsored by Avanir Pharmaceuticals.
NCT01667679 is a Phase 3 study that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 275 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01667679, a Phase 3 study, has completed, sponsored by Avanir Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
Study Summary
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.
Primary Outcome
SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysi
Interventions
- DRUG 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
- DRUG OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01667679 record still lists
NCT01667679 is an interventional study that assigns participants to a tested intervention. The registered 275 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally is the first listed.
NCT01667679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01667679 about?
NCT01667679 is a clinical study titled "Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura". This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.
What is the current status of trial NCT01667679?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2012-08. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01667679?
The interventions under investigation include: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally (DRUG), OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet (DRUG).
Who is sponsoring clinical trial NCT01667679?
This trial is sponsored by Avanir Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01667679's enrollment target sits among peer trials
275 1206th of 2000 higher than 794 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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