Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

This study has been terminated.
(Enrollment rate was slower than anticipated.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.
ClinicalTrials.gov Identifier:
NCT01053507
First received: January 19, 2010
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Post-Traumatic Headache
Interventions: Drug: sumatriptan/naproxen sodium
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
Treximet

In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.

sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Placebo

In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.

Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.


Participant Flow:   Overall Study
    Treximet     Placebo  
STARTED     11     12  
COMPLETED     8     11  
NOT COMPLETED     3     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.
No text entered.

Reporting Groups
  Description
Treximet

In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.

sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Placebo

In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.

Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Total Total of all reporting groups

Baseline Measures
    Treximet     Placebo     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age  
[units: years]
Mean ± Standard Deviation
  41.36  ± 9.83     35.83  ± 12.01     38.48  ± 11.14  
Gender  
[units: participants]
     
Female     6     9     15  
Male     5     3     8  
Region of Enrollment  
[units: participants]
     
United States     11     12     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Headache Days   [ Time Frame: Day 0, Day +30 ]

2.  Primary:   Associated Headache Symptoms   [ Time Frame: Day 0, Day +30 ]

3.  Secondary:   Mental Efficiency Workload Test (MEWT) Performance Index   [ Time Frame: Day 0, Day +30 ]

4.  Secondary:   Headache Impact Test-6 (HIT-6) Score   [ Time Frame: Day 0, Day +30 ]

5.  Secondary:   Migraine Specific Quality of Life Questionnaire (MSQ)   [ Time Frame: Day 0, Day +30 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Roger K. Cady
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: NCT01053507     History of Changes
Other Study ID Numbers: 114126
Study First Received: January 19, 2010
Results First Received: January 28, 2014
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board