Treximet in Acute Migraine Headache: Assessing Cognitive Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00837044|
Recruitment Status : Unknown
Verified February 2009 by Neurological Research Center.
Recruitment status was: Recruiting
First Posted : February 5, 2009
Last Update Posted : February 5, 2009
Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported.
The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control.
It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache Cognitive Impairment||Drug: Treximet Drug: Migraine rescue medication of choice||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function.|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||September 2009|
Active Comparator: 1
Treximet, cognitive testing
Other Name: Sumatriptan succinate 85mg/Naproxen Sodium 500mg
Placebo Comparator: 2
Placebo, Cognitive testing
Drug: Migraine rescue medication of choice
Migraine rescue medication of choice
- To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine. [ Time Frame: 2 hours post dose ]
- To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment. [ Time Frame: 2 hours post dose ]
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): NCT00837044
|Contact: Judith R Button, BS/CRC||802-447-7577 ext firstname.lastname@example.org|
|Contact: Carol L Gorman, LPN/CCRC||802-447-7577 ext email@example.com|
|United States, Vermont|
|The Neurological Research center, Inc||Recruiting|
|Bennington, Vermont, United States, 05201`|
|Principal Investigator: Keith R Edwards, MD|
|Principal Investigator:||Keith R Edwards, M.D.||The Neurological Research Center, Inc.|