Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Public ClinicalTrials.gov record NCT01462812. 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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine With or Without Aura
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01462812
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 223 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- Jan 2011 (Type not available)
- Primary completion
- Jun 2012 (Actual)
- Completion
- Jun 2012 (Actual)
- Last update posted
- May 6, 2015
2011 – 2012
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| San Francisco Clinical Research Center | San Francisco | California | 94109 | — |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | — |
| Associated Neurologists of Southern CT, P.C. | Fairfied | Connecticut | 06824 | — |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| MedVadis | Watertown | Massachusetts | 02472 | — |
| Michigan Head and Pain Institute | Ann Arbor | Michigan | 48104-5199 | — |
| ClinVest | Springfield | Missouri | 65807 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| DENT Neurologic Institute | Amherst | New York | 14226 | — |
| Headache Wellnes Center | Greensboro | North Carolina | 27405 | — |
| PMG Research of Raleigh North carolina, LLC | Raleigh | North Carolina | 27609 | — |
| PMG Research of Winston Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Neurology Center of Ohio | Toledo | Ohio | 43623 | — |
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
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 NCT01462812, 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 May 6, 2015 · Synced Oct 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01462812 live on ClinicalTrials.gov.