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Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

NCT01053507 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-07-29

Study results available
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Summary

This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.

Conditions

  • Post-Traumatic Headache

Interventions

DRUG

sumatriptan/naproxen sodium

Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

DRUG

Placebo

Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days 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
2010-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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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 NCT01053507 on ClinicalTrials.gov