Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
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.
Drug: sumatriptan/naproxen sodium
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction|
- Headache Days [ Time Frame: Day 0, Day +30 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.
- Mental Efficiency Workload Test (MEWT) Performance Index [ Time Frame: Day 0, Day +30 ] [ Designated as safety issue: No ]
- Headache Impact Test-6 (HIT-6) Score [ Time Frame: Day 0, Day +30 ] [ Designated as safety issue: No ]
- Migraine Specific Quality of Life Questionnaire (MSQ) [ Time Frame: Day 0, Day +30 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Drug: 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.
Other Name: Treximet
Placebo Comparator: Placebo
In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
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.
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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053507
|United States, Missouri|
|Springfield, Missouri, United States, 65807|
|United States, Tennessee|
|Nashville Neuroscience Group, PC|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Scott & White Memorial Hospital and Clinic|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Roger K Cady, MD||Clinvest|