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Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura (COMPASS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01667679
First received: August 6, 2012
Last updated: March 14, 2017
Last verified: March 2017
Results First Received: October 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Migraine
Headaches
Interventions: Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 334 participants were assessed for eligibility; of these, 275 participants were randomized.

Reporting Groups
  Description
20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) In Treatment Period (TP) 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.

Participant Flow for 2 periods

Period 1:   Treatment Period 1 (<=12 Weeks)
    20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)   100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
STARTED   138   137 
COMPLETED   122   107 
NOT COMPLETED   16   30 
Failure to Treat Migraine Headache                2                6 
Dosed Incorrectly                2                0 
Lack of Efficacy                2                0 
Could Not Tolerate Diary                1                0 
Withdrawal by Subject                6                13 
Adverse Event                3                3 
Lost to Follow-up                0                2 
Protocol Violation                0                2 
Non-compliance                0                3 
Moved Out of State                0                1 

Period 2:   Treatment Period 2 (<=12 Weeks)
    20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)   100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
STARTED   122   107 
COMPLETED   100   85 
NOT COMPLETED   22   22 
Withdrawal by Subject                6                4 
Non-compliance with Electronic Diary                2                0 
Lost to Follow-up                8                10 
Non-compliance                3                4 
Sponsor Decision                1                0 
Failure to Treat Migraine Headache                1                0 
Adverse Event                1                0 
Significant Improvement in Migraine                0                1 
Partially Dosed                0                1 
Brought in before 12 Weeks/5 Migraines                0                1 
Refused Last Day of Visit 4 Procedures                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline data are reported for participants in the Safety Analysis Set, defined as all randomized participants who received at least one dose of sumatriptan (20 mg nasal powder or 100 mg tablet).

Reporting Groups
  Description
20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.
100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.
Total Total of all reporting groups

Baseline Measures
   20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)   100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   129   262 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.5  (12.55)   40.7  (11.93)   40.1  (12.24) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      107  80.5%      115  89.1%      222  84.7% 
Male      26  19.5%      14  10.9%      40  15.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      3   2.3%      1   0.8%      4   1.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      24  18.0%      26  20.2%      50  19.1% 
White      104  78.2%      100  77.5%      204  77.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   1.5%      2   1.6%      4   1.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Sum of Migraine Pain Intensity Differences (SPID)-30   [ Time Frame: Baseline and 30 minutes post-dose (up to 24 weeks) ]

2.  Secondary:   Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe   [ Time Frame: Baseline and 30 minutes post-dose (up to 24 weeks) ]

3.  Secondary:   Percentage of Attacks in Which Pain Reduction Was Achieved   [ Time Frame: 10, 15, 30, 45, 60, 90, and 120 minutes ]

4.  Secondary:   Percentage of Attacks in Which Pain Freedom Was Achieved   [ Time Frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) ]

5.  Secondary:   Percentage of Attacks in Which Pain Relief Was Achieved   [ Time Frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) ]

6.  Secondary:   Median Time to Pain Freedom   [ Time Frame: 120 minutes post-dose (up to 24 weeks) ]

7.  Secondary:   Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose   [ Time Frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) ]

8.  Secondary:   Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose   [ Time Frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) ]

9.  Secondary:   Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event   [ Time Frame: Baseline compared to Vist 2, 3 and 4 ]

10.  Secondary:   Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

11.  Secondary:   Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

12.  Secondary:   Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

13.  Secondary:   Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

14.  Secondary:   Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

15.  Secondary:   Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

16.  Secondary:   Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

17.  Secondary:   Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

18.  Secondary:   Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

19.  Secondary:   Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

20.  Secondary:   Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

21.  Secondary:   Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

22.  Secondary:   Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

23.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

24.  Secondary:   Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

25.  Secondary:   Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

26.  Secondary:   Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)   [ Time Frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) ]

27.  Secondary:   Number of Participants With the Indicated Concomitant Medications   [ Time Frame: up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nadine Knowles; Executive Director, Research & Development Operations
Organization: Avanir Pharmaceuticals
phone: 1-949-268-8972
e-mail: nknowles@avanir.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01667679     History of Changes
Other Study ID Numbers: OPN-SUM-MIG-3302
Study First Received: August 6, 2012
Results First Received: October 13, 2016
Last Updated: March 14, 2017