Clinical trial NCT01462812: Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Headache
Keywords: Migraine
Headache
Sumatriptan
Lead sponsor: Optinose US Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-31
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 headaches.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Headache Relief
timeFrame: 120 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Fairfied
country: United States
facility: Associated Neurologists of Southern CT, P.C.
state: Connecticut
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Watertown
country: United States
facility: MedVadis
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head and Pain Institute
state: Michigan
city: Springfield
country: United States
facility: ClinVest
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Amherst
country: United States
facility: DENT Neurologic Institute
state: New York
city: Greensboro
country: United States
facility: Headache Wellnes Center
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh North carolina, LLC
state: North Carolina
city: Winston Salem
country: United States
facility: PMG Research of Winston Salem, LLC
state: North Carolina
city: Toledo
country: United States
facility: Neurology Center of Ohio
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
Study officials:
References:
citation: Cady RK, McAllister PJ, Spierings EL, Messina J, Carothers J, Djupesland PG, Mahmoud RA. A randomized, double-blind, placebo-controlled study of breath powered nasal delivery of sumatriptan powder (AVP-825) in the treatment of acute migraine (The TARGET Study). Headache. 2015 Jan;55(1):88-100. doi: 10.1111/head.12472. Epub 2014 Oct 30.