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1 for Migraine

N/A
Waitlist Available
Led By Keith R Edwards, M.D.
Research Sponsored by Neurological Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours post dose
Awards & highlights

Study Summary

Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported. The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control. It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.

Eligible Conditions
  • Migraine
  • Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine.
Secondary outcome measures
To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 1Active Control1 Intervention
Treximet, cognitive testing
Group II: 2Placebo Group1 Intervention
Placebo, Cognitive testing

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Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,805 Total Patients Enrolled
13 Trials studying Migraine
2,584 Patients Enrolled for Migraine
Neurological Research CenterLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Keith R Edwards, M.D.Principal InvestigatorThe Neurological Research Center, Inc.
3 Previous Clinical Trials
129 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Apr 2025