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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Drug: Sumatriptan
Drug: Placebo
Enrollment 223
Recruitment Details private practices and research clinics
Pre-assignment Details Screening period (general medical exams, labs, medical and headache history, concomitant medications.
Arm/Group Title Matching Placebo Sumatriptan
Hide Arm/Group Description Placebo : Matching placebo Sumatriptan : Sumatriptan 20mg
Period Title: Overall Study
Started 111 112
Completed 111 111
Not Completed 0 1
Arm/Group Title Matching Placebo Sumatriptan Total
Hide Arm/Group Description Placebo : Matching placebo Sumatriptan : Sumatriptan 20mg Total of all reporting groups
Overall Number of Baseline Participants 111 112 223
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 112 participants 223 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
111
 100.0%
112
 100.0%
223
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 112 participants 223 participants
42.3  (10.71) 42.2  (10.27) 42.2  (10.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 112 participants 223 participants
Female
93
  83.8%
94
  83.9%
187
  83.9%
Male
18
  16.2%
18
  16.1%
36
  16.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 112 participants 223 participants
111 112 223
1.Primary Outcome
Title Headache Relief
Hide 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.
Time Frame 120 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses.
Arm/Group Title Matching Placebo Sumatriptan
Hide Arm/Group Description:
Placebo : Matching placebo
Sumatriptan : Sumatriptan 20mg
Overall Number of Participants Analyzed 104 108
Measure Type: Number
Unit of Measure: participants
47 73
Time Frame 17 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Matching Placebo Sumatriptan
Hide Arm/Group Description Placebo : Matching placebo Sumatriptan : Sumatriptan 20mg
All-Cause Mortality
Matching Placebo Sumatriptan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Matching Placebo Sumatriptan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/111 (0.00%)   0/112 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Matching Placebo Sumatriptan
Affected / at Risk (%) Affected / at Risk (%)
Total   9/111 (8.11%)   45/112 (40.18%) 
General disorders     
Product Taste Abnormal * 1  4/111 (3.60%)  25/112 (22.32%) 
Infections and infestations     
Rhinitis * 2  0/111 (0.00%)  3/112 (2.68%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Discomfort * 1  2/111 (1.80%)  15/112 (13.39%) 
Rhinorrhoea * 1  3/111 (2.70%)  6/112 (5.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
2
Term from vocabulary, Medra 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Found in PI contract.
Results Point of Contact
Name/Title: Sr. Director of Clinical Development
Organization: OptiNose
Phone: (267) 364-3620
Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01462812     History of Changes
Other Study ID Numbers: OPN-SUM-MIG-3301
First Submitted: October 27, 2011
First Posted: October 31, 2011
Results First Submitted: April 20, 2015
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015