Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
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|ClinicalTrials.gov Identifier: NCT01053507|
Recruitment Status : Terminated (Enrollment rate was slower than anticipated.)
First Posted : January 21, 2010
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Headache||Drug: sumatriptan/naproxen sodium Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|