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1 for Cognitive Impairment

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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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
  • Cognitive Impairment
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
4,802 Previous Clinical Trials
8,377,972 Total Patients Enrolled
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
~2 spots leftby Nov 2025