Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

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.

Timeline

Start

2010-05

Primary completion

2012-11

Completion

2012-11

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment rate was slower than anticipated.”

Publications

• Background Baandrup L, Jensen R. Chronic post-traumatic headache--a clinical analysis in relation to the International Headache Classification 2nd Edition. Cephalalgia. 2005 Feb;25(2):132-8. doi: 10.1111/j.1468-2982.2004.00818.x.
• Background Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
• Background Cady R, Farmer K. Soft tissue injuries: diagnosis and treatment. Posttraumatic headache. In Windsor R, Lox D (eds.) Hanley and Belfus, Inc. Philadelphia, PA. 207-224.

Drugs

Indications