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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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ClinicalTrials.gov Identifier: NCT01462812
Recruitment Status : Completed
First Posted : October 31, 2011
Results First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.

Tracking Information
First Submitted Date  ICMJE October 27, 2011
First Posted Date  ICMJE October 31, 2011
Results First Submitted Date  ICMJE April 20, 2015
Results First Posted Date  ICMJE May 6, 2015
Last Update Posted Date May 6, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
Headache Relief [ Time Frame: 120 Minutes ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01462812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: Sumatriptan
    Sumatriptan 20mg
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Active Comparator: Sumatriptan
    Intervention: Drug: Sumatriptan
  • Placebo Comparator: Matching placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
223
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2011)
200
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01462812
Other Study ID Numbers  ICMJE OPN-SUM-MIG-3301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Optinose US Inc.
Study Sponsor  ICMJE Optinose US Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Optinose US Inc.
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP