Clinical Trial: Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

Brief Summary: This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.

Detailed Summary: Subjects will be enrolled at 3 investigative sites. At Visit 1, a medical, headache, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An ECG will be completed if one has not been completed in the previous 6 months. Subjects will be administered a series of psychological tests to help the study doctor decide whether or not a subject is eligible. The Headache Impact Test-6 and Migraine Specific Quality of Life Questionnaire will be completed at each visit. During a 30-day Baseline Period, subjects will treat with their usual medication and complete a daily Diary documenting headache symptoms and treatment. At Visits 2 and 3 subjects will complete the Mental Efficiency Workload Test and Migraine Early Warning Tool. Following randomization at Visit 2, subjects will treat daily for 30 days with Treximet or a matching placebo. Subjects will be provided with Treximet for rescue of any persisting or recurring headache. During the Treatment Period, subjects will complete a daily Diary reporting headache symptoms and response to treatment. After the 30-day Treatment Period, subjects will exit the study at Visit 3 .
Sponsor: Cady, Roger, M.D.

Current Primary Outcome:

  • Headache Days [ Time Frame: Day 0, Day +30 ]
    Change in number of headache days at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.
  • Associated Headache Symptoms [ Time Frame: Day 0, Day +30 ]
    Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.


Original Primary Outcome:

  • Headache Days [ Time Frame: Day 0, Day +30 ]
  • Associated Headache Symptoms [ Time Frame: Day 0, Day +30 ]


Current Secondary Outcome:

  • Mental Efficiency Workload Test (MEWT) Performance Index [ Time Frame: Day 0, Day +30 ]
  • Headache Impact Test-6 (HIT-6) Score [ Time Frame: Day 0, Day +30 ]
  • Migraine Specific Quality of Life Questionnaire (MSQ) [ Time Frame: Day 0, Day +30 ]


Original Secondary Outcome: Same as current

Information By: Cady, Roger, M.D.

Dates:
Date Received: January 19, 2010
Date Started: May 2010
Date Completion:
Last Updated: January 28, 2014
Last Verified: January 2014