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Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex

NCT01450995 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-10-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Treximet

Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.

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

Sponsors & Collaborators

Principal Investigators

  • Stephen H Landy, M.D. · Wesley Headache Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450995 on ClinicalTrials.gov