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

Optinose

Status and phase

Completed

Phase 3

Conditions

Migraine Headache

Treatments

Drug: Placebo

Drug: Sumatriptan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01462812

OPN-SUM-MIG-3301

Details and patient eligibility

About

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.

Full 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 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.

Enrollment

223 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)