Status:
COMPLETED
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Lead Sponsor:
Optinose US Inc.
Conditions:
Migraine Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 h...
Detailed Description
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 min...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01462812
Start Date
January 1 2011
End Date
June 1 2012
Last Update
May 6 2015
Active Locations (15)
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1
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
2
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
3
Associated Neurologists of Southern CT, P.C.
Fairfied, Connecticut, United States, 06824
4
Premiere Research Institute
West Palm Beach, Florida, United States, 33407