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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01462812
Other study ID # OPN-SUM-MIG-3301
Secondary ID
Status Completed
Phase Phase 3
First received October 27, 2011
Last updated April 20, 2015
Start date January 2011
Est. completion date June 2012

Study information

Verified date August 2012
Source Optinose US Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 223
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sumatriptan
Sumatriptan 20mg
Placebo
Matching placebo

Locations

Country Name City State
United States DENT Neurologic Institute Amherst New York
United States Michigan Head and Pain Institute Ann Arbor Michigan
United States Associated Neurologists of Southern CT, P.C. Fairfied Connecticut
United States Headache Wellnes Center Greensboro North Carolina
United States Coastal Carolina Research Center Mt. Pleasant South Carolina
United States Jefferson Headache Center Philadelphia Pennsylvania
United States PMG Research of Raleigh North carolina, LLC Raleigh North Carolina
United States San Francisco Clinical Research Center San Francisco California
United States California Medical Clinic for Headache Santa Monica California
United States ClinVest Springfield Missouri
United States Mercy Health Research St. Louis Missouri
United States Neurology Center of Ohio Toledo Ohio
United States MedVadis Watertown Massachusetts
United States Premiere Research Institute West Palm Beach Florida
United States PMG Research of Winston Salem, LLC Winston Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Optinose US Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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