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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
223
Sumatriptan 20mg
Matching placebo
San Francisco Clinical Research Center
San Francisco, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Headache Relief
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.
Time frame: 120 Minutes
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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
...and 5 more locations