"Completeness of Response" Following Treatment With Treximet™ for Migraine
|Migraine||Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study to Evaluate "Completeness of Response" Following Treatment With Treximet™ for Migraine|
- Change in Scores From Completeness of Response Survey (CORS) [ Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) ]
CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.
The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication).
- Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan [ Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) ]CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.
- Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R) [ Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) ]Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.
|Study Start Date:||June 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.
At the screening visit (Visit 1), following written informed consent, subjects will provide a medical, medication and migraine history. A physical and neurological exam and pregnancy test (if appropriate) will be performed. Vital signs will be recorded for all subjects. The Headache Impact Test (HIT-6) and Baseline Patient Perception of Migraine Questionnaire (PPMQ-R) will be completed with the Baseline Completeness of Response Survey (CORS) considering migraine therapy (triptan) utilized during the 3 months prior to enrollment. The Completeness of Response Survey will collect traditional and non-traditional symptoms. Subjects are instructed to treat all migraines that occur in the next 2 months. Subjects will treat with a single tablet of Treximet™ as soon as they have a headache indicative of migraine and are encouraged to treat when the headache is mild. A Headache Diary documenting onset of headache pain and associated symptoms, time of treatment with study medication, symptoms at 2 hours following treatment, time of relief, recurrence of symptoms within 24 hours post-treatment, and adverse events will be dispensed with study medication. Subjects may take a 2nd dose of study medication or medication determined by the investigator for rescue of persistent or recurring headache at 2 or more hours following the 1st dose of study medication. Alternate rescue medication can be provided at the discretion of the investigator but may not include triptan, non-steroidal anti-inflammatory (short-acting NSAID between 6 hours before and 2 hours after study medication or long-acting NSAID between 24 hours before and 24 hours after study medication), or ergotamine-containing or ergot-type medication. Subjects must be headache-free for 24 hours before recording the onset of a "new" migraine attack. The study coordinator will contact subjects at Month 1 to verify treatment and diary compliance.
At Visit 2, following 2 months of treatment with Treximet™, the subject will return to the study site and return completed Headache Diaries. The End of Study CORS, CORS Comparator and End of Study PPMQ-R will be completed considering response with study medication. Adverse events will be documented and Diaries and Questionnaires will be reviewed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893737
|United States, California|
|San Francisco Clinical Research Center|
|San Francisco, California, United States, 94109|
|United States, Michigan|
|Westside Family Medical Center|
|Kalamazoo, Michigan, United States, 49009|
|United States, Missouri|
|Springfield, Missouri, United States, 65807|
|Mercy Health Research/Ryan Headache Center|
|St. Louis, Missouri, United States, 63141|
|United States, New York|
|Island Neurological Associates, PC|
|Plainview, New York, United States, 11803|
|United States, Pennsylvania|
|Preferred Primary Care Physicians|
|Pittsburgh, Pennsylvania, United States, 15236|
|United States, Tennessee|
|Wesley Headache Clinic and Research Center|
|Cordova, Tennessee, United States, 38018|
|United States, Texas|
|Texas Headache Associates|
|San Antonio, Texas, United States, 78258|
|Principal Investigator:||Roger K Cady, MD||Clinvest|