Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01462812 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
A Phase 3 study, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 223
- Enrollment target
NCT01462812: Completed Phase 3 study, sponsored by Optinose US.
NCT01462812 is a Phase 3 study that has completed, run by Optinose US. The registered enrollment target is 223 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01462812, a Phase 3 study, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 223 participants
- Enrollment target
Study Summary
The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.
Primary Outcome
The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.
Interventions
- DRUG Placebo
- DRUG Sumatriptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01462812 record still lists
NCT01462812 is an interventional study that assigns participants to a tested intervention. The registered 223 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01462812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01462812 about?
NCT01462812 is a clinical study titled "Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine". The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.
What is the current status of trial NCT01462812?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 223 participants. The study started on 2011-01. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01462812?
The interventions under investigation include: Placebo (DRUG), Sumatriptan (DRUG).
Who is sponsoring clinical trial NCT01462812?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01462812's enrollment target sits among peer trials
223 1317th of 2000 higher than 684 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06640803 · 223 participants · NA
Sacramento Clinical High Risk for Psychosis Stepped-Care Program
- NCT07175285 · 223 participants
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
- NCT07205718 · 223 participants · Phase 1
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
- NCT02706561 · 224 participants · NA
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia