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Treximet in Acute Migraine Headache: Assessing Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00837044
Recruitment Status : Unknown
Verified February 2009 by Neurological Research Center.
Recruitment status was:  Recruiting
First Posted : February 5, 2009
Last Update Posted : February 5, 2009
Information provided by:
Neurological Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Headache Cognitive Impairment Drug: Treximet Drug: Migraine rescue medication of choice Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function.
Study Start Date : February 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: 1
Treximet, cognitive testing
Drug: Treximet
Other Name: Sumatriptan succinate 85mg/Naproxen Sodium 500mg

Placebo Comparator: 2
Placebo, Cognitive testing
Drug: Migraine rescue medication of choice
Migraine rescue medication of choice

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 hours post dose ]

Secondary Outcome Measures :
  1. To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment. [ Time Frame: 2 hours post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Females and male subjects, ages 18-65 inclusive
  2. Have migraines with or without aura as expressed by the International Headache Society (IHS) criteria for at least six months and at least one attack per month for three months prior to screening
  3. If female, have an acceptable method of contraception during the study, have no plans to become pregnant and have a negative urine pregnancy test at screening and throughout the study.
  4. Must be able to follow study protocol including all neuropsychological testing, MEWT assessments and evaluation forms.
  5. Must be willing and able to provide written informed consent

Exclusion Criteria:

  1. Have more than 15 headache days per month
  2. Have hemiplegic or secondary headaches
  3. Have significant risk factors for cardiovascular or cerebrovascular disease as assessed by the investigator
  4. Are taking any medication that is contraindicated with a triptan or NSAIDs
  5. Have any significant concomitant disease
  6. Have any allergy to triptans, aspirin or NSAIDs
  7. Have a history of substance abuse, psychiatric illness in the last 5 years
  8. Are participating or have participated in an investigational drug trial within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00837044

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Contact: Judith R Button, BS/CRC 802-447-7577 ext 104
Contact: Carol L Gorman, LPN/CCRC 802-447-7577 ext 108

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United States, Vermont
The Neurological Research center, Inc Recruiting
Bennington, Vermont, United States, 05201`
Principal Investigator: Keith R Edwards, MD         
Sponsors and Collaborators
Neurological Research Center
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Principal Investigator: Keith R Edwards, M.D. The Neurological Research Center, Inc.

Farmer K, Cady R, Reeves D, Bleiberg J. Cognitive efficiency following migraine therapy. In: J. Olsen, T.J. Steiner, R.B. Lipton (Eds.) Reducing the burden of headache: Frontiers in headache research (pp 46-51) New York: Oxford University Press 2003

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Keith R. Edwards, M.D., The Neurological Research Center, Inc Identifier: NCT00837044     History of Changes
Other Study ID Numbers: 112488
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Migraine Disorders
Cognitive Dysfunction
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists