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Trial record 1 of 3 for:    16686915 [PUBMED-IDS]
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Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

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ClinicalTrials.gov Identifier: NCT01300546
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Migraine
Interventions: Drug: Sumatriptan/Naproxen Sodium
Drug: Naproxen Sodium

  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 (11-30-10) until date last patient enrolled (1/3/12). 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 must complete a 30 day Baseline Period between Visit 1 and Visit 2 before Randomization. Subjects must have had 6-14 headache days during the 30 day Baseline Period in order to be Randomized into the Study Treatment Period. Fifty nine subjects were screened for study; however, only 39 subjects randomized for treatment due to screen fail.

Reporting Groups
  Description
Sumatriptan/Naproxen Sodium In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
Naproxen Sodium In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.

Participant Flow:   Overall Study
    Sumatriptan/Naproxen Sodium   Naproxen Sodium
STARTED   19   20 
COMPLETED   18   14 
NOT COMPLETED   1   6 
Withdrawal by Subject                1                0 
Lost to Follow-up                0                2 
Lack of Efficacy                0                3 
Adverse Event                0                1 



  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, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
Naproxen Sodium In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
Total Total of all reporting groups

Baseline Measures
   Sumatriptan/Naproxen Sodium   Naproxen Sodium   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   20   39 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   19   20   39 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.7  (9.6)   43.1  (9.3)   39.5  (10.1) 
Gender 
[Units: Participants]
     
Female   17   19   36 
Male   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   19   20   39 


  Outcome Measures

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

2.  Secondary:   Migraine Attacks   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121. ]

3.  Secondary:   Migraine Severity   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121. ]

4.  Secondary:   Migraine 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. ]

5.  Secondary:   Migraine 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. ]

6.  Secondary:   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, 91, and 121. ]

7.  Secondary:   Migraine Attacks With 50% Reduction   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121. ]

8.  Secondary:   Doses of Study Medication   [ Time Frame: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121. ]

9.  Secondary:   Percent Change of Doses of Study Medication   [ Time Frame: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121. ]

10.  Secondary:   Migraine Disability Assessment Test (MIDAS)   [ Time Frame: Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121. ]

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

12.  Secondary:   Percent Change in Headache Days All Treatment Periods Compared to Baseline   [ Time Frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121. ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications:


Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01300546     History of Changes
Other Study ID Numbers: 114933
First Submitted: January 12, 2011
First Posted: February 21, 2011
Results First Submitted: February 1, 2013
Results First Posted: May 21, 2013
Last Update Posted: May 21, 2013