Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex
This is an open label, 6 month cross over study in 50 migraine patients fulfilling International Headache Society Classification criteria for migraine headache with and without aura having 2-6 migraines per month and not over 14 days a month of headaches in the previous 3 months. Baseline Headache Impact Test -6 (HIT-6) will be obtained and 25 patients will administer Treximet as needed for 3 months and then 2 Aleve and 100mg Imitrex taken concomitantly as needed for 3 months. The other 25 patients will administer 2 Aleve and 100mg Imitrex taken concomitantly as needed for 3 months and then Treximet as needed for 3 months. In addition to Revised Patient Perception of Migraine Questionnaire (PPMQ-R)data, a detailed diary will be recorded regarding number of tablets taken per attack, compliance, rescue treatment, when patients treated their migraine attack (mild, moderate, or severe), onset of pain reduction (pain relief and pain free, and 24 hour pain relief and sustained pain free response.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, 6 Month Crossover Study Evaluating Migraine Patient Satisfaction Comparing Treximet to 2 Aleve and 100mg Imitrex Taken Concomitantly|
- Measurement of patient satisfaction of Treximet vs 2 Aleve and 100mg Imitrex [ Time Frame: one year ] [ Designated as safety issue: No ]
- Measurement of time to onset of pain relief [ Time Frame: One year ] [ Designated as safety issue: No ]
- Measurement of time to onset of pain free [ Time Frame: one year ] [ Designated as safety issue: No ]
- Measurement of 24 hour sustained pain free [ Time Frame: One year ] [ Designated as safety issue: No ]
- Measurement of 24 hour sustained pain relief [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Treximet||
Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.
|Active Comparator: Imitrex and Aleve||
Drug: Imitrex and two Aleve
Imitrex tablet, one tablet dose, Aleve tablets, 2 220 mg tablet dose. Three tablets taken concurrently with migraine onset. Second dose of tablets may be taken if migraine persists for two hours
A migraine headache is characterized by pain felt on one and sometimes both side(s) of the head. Other symptoms associated with a migraine headache may include nausea, vomiting, and sensitivity to light and sound. A migraine can last a few hours or up to one or two days.
Triptan medications are currently thought to be safe and effective for acute migraine treatment. Treximet(tm) is a triptan tablet containing a combination of sumatriptan 85mg (Imitrex) and naproxen sodium 500 mg.
This combination has two methods of action for relieving a migraine headache. It targets the nerves and blood vessels involved in a migraine, and relieves inflammation that may cause migraine pain. Treximet(tm), is approved by the Food and Drug Administration.
The purpose of this research study is to compare the effectiveness of taking Treximet(tm) as a combination pill to taking two Aleve(r) tablets and 100mg of Imitrex(r) as separate tablets taken at the same time.
|United States, Tennessee|
|Wesley Headache Clinic|
|Memphis, Tennessee, United States, 38018|
|Principal Investigator:||Stephen H Landy, M.D.||Wesley Headache Clinic|