Treximet in the Treatment of Chronic Migraine

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.
ClinicalTrials.gov Identifier:
NCT01090050
First received: March 18, 2010
Last updated: May 29, 2013
Last verified: May 2013
Results First Received: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Migraine
Interventions: Drug: Sumatriptan/Naproxen Sodium
Drug: Naproxen Sodium

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was from date of Institutional Review Board (IRB) approval (8-3-10) until date last patient enrolled (1-30-12). Subjects were recruited from general population at two clinical research centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects completed a 30 day Baseline period between Visit 1 and Visit 2 before Randomization. Subjects must have had 15 or more headache days during the 30 day Baseline period in order to be randomized into the study Treatment periods. Fifty-six subjects were screened for study, however only 28 subjects randomized for treatment due to screen fail.

Reporting Groups
  Description
Sumatriptan/Naproxen Sodium In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
Naproxen Sodium In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.

Participant Flow:   Overall Study
    Sumatriptan/Naproxen Sodium     Naproxen Sodium  
STARTED     16     12  
COMPLETED     15     5  
NOT COMPLETED     1     7  
Lost to Follow-up                 0                 1  
Lack of Efficacy                 1                 5  
Physician Decision                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Sumatriptan/Naproxen Sodium In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue.
Naproxen Sodium In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue.
Total Total of all reporting groups

Baseline Measures
    Sumatriptan/Naproxen Sodium     Naproxen Sodium     Total  
Number of Participants  
[units: participants]
  16     12     28  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     12     28  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.8  ± 12.6     37.0  ± 8.6     40.9  ± 11.4  
Gender  
[units: participants]
     
Female     12     10     22  
Male     4     2     6  
Region of Enrollment  
[units: participants]
     
United States     16     12     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change of Migraine Headache Days Compared to Baseline   [ Time Frame: Day 121 (following 30 day Baseline Period and Treatment Period days 91-120. ]

2.  Secondary:   Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline   [ Time Frame: Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively. ]

3.  Secondary:   Migraine Headache Duration From Onset to Pain Free   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively. ]

4.  Secondary:   Migraine Headache Duration From Time of Treatment to Pain Free   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively. ]

5.  Secondary:   Migraine Headache Days With Greater Than 50% Reduction   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively. ]

6.  Secondary:   Percent Change of Doses of Study Medication   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively. ]

7.  Secondary:   Migraine Disability Assessment(MIDAS)Questionnaire Total Score   [ Time Frame: Baseline MIDAS collected at Day 31, Post final dose study at Day 121. ]

8.  Secondary:   Compliance With Lifestyle Changes   [ Time Frame: Day 121 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeanne Tarrasch
Organization: Clinvest/A Division of Banyan Group Inc.
phone: 417-841-3673
e-mail: jtarrasch@clinvest.com


No publications provided


Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01090050     History of Changes
Other Study ID Numbers: 112839
Study First Received: March 18, 2010
Results First Received: February 5, 2013
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board