Clinical trial NCT00893737
Conditions: Migraine
Keywords: Migraine Headache, Migraine
Sponsor: Cady, Roger, M.D.
Start date: 2009-06-01; Completion date: 2010-01-01
Enrollment: 147 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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™).

Detailed description:
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.

Arms: arm 1: 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.
Interventions: intervention 1: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
Intervention descriptions: intervention 1: 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.

Protocol documents: