"Completeness of Response" Following Treatment With Treximet™ for Migraine
Many clinical trials may not fully explore criteria that are important to some migraine patients' definition of "complete response." This study offers the opportunity to evaluate the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2 visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2 considering their study medication (Treximet™).
Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
|Study Design:||Endpoint Classification: Efficacy Study
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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|