Clareo Health | Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
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Lead
Optinose US Inc.
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
