Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Headache

In brief

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.

Key facts

Study ID

NCT01462812

Run by

Optinose US Inc.

People needed

223

Starts

2011-01-01

Expected to finish

2012-06-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women, between the ages of 18 to 65 years
• Diagnosis of migraine, with or without aura
• Experiences between 1 and 8 migraine attacks per month for the past 12 months

You may not qualify if…

• Inability to distinguish other headaches from migraine
• Experiences headache of any kind at a frequency greater than or equal to 15 days per month
• History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment
• Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
• Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)

Where it is running

• San Francisco Clinical Research Center — San Francisco, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• Associated Neurologists of Southern CT, P.C. — Fairfied, Connecticut, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• MedVadis — Watertown, Massachusetts, United States
• Michigan Head and Pain Institute — Ann Arbor, Michigan, United States
• ClinVest — Springfield, Missouri, United States
• Mercy Health Research — St Louis, Missouri, United States
• DENT Neurologic Institute — Amherst, New York, United States
• Headache Wellnes Center — Greensboro, North Carolina, United States
• PMG Research of Raleigh North carolina, LLC — Raleigh, North Carolina, United States
• PMG Research of Winston Salem, LLC — Winston-Salem, North Carolina, United States
• Neurology Center of Ohio — Toledo, Ohio, United States
• Jefferson Headache Center — Philadelphia, Pennsylvania, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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