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Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

NCT01300546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-05-21

Study results available
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Summary

This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.

Conditions

Interventions

DRUG

Sumatriptan/Naproxen Sodium

Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.

DRUG

Naproxen Sodium

Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.

Sponsors & Collaborators

Principal Investigators

  • Roger K Cady, MD · Clinvest

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

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 NCT01300546 on ClinicalTrials.gov