Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
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
1 other identifier
interventional
223
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 27, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
May 6, 2015
CompletedMay 6, 2015
August 1, 2012
1.4 years
October 27, 2011
April 20, 2015
April 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
120 Minutes
Study Arms (2)
Sumatriptan
ACTIVE COMPARATORMatching placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify 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 qualify 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Optinose US Inc.lead
Study Sites (15)
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Associated Neurologists of Southern CT, P.C.
Fairfied, Connecticut, 06824, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
MedVadis
Watertown, Massachusetts, 02472, United States
Michigan Head and Pain Institute
Ann Arbor, Michigan, 48104-5199, United States
ClinVest
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
DENT Neurologic Institute
Amherst, New York, 14226, United States
Headache Wellnes Center
Greensboro, North Carolina, 27405, United States
PMG Research of Raleigh North carolina, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Winston Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Neurology Center of Ohio
Toledo, Ohio, 43623, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Related Publications (1)
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.
PMID: 25355310DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director of Clinical Development
- Organization
- OptiNose
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2011
First Posted
October 31, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 6, 2015
Results First Posted
May 6, 2015
Record last verified: 2012-08