Treximet in Acute Migraine Headache: Assessing Cognitive Function

NCT00837044 | Unknown

• 1 other identifier: 112488
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache; Cognitive Impairment

Outcome Measures

Primary Outcomes (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.

  2 hours post dose

Secondary Outcomes (1)

• To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment.

  2 hours post dose

Study Arms (2)

1

ACTIVE COMPARATOR

Treximet, cognitive testing

Drug: Treximet

2

PLACEBO COMPARATOR

Placebo, Cognitive testing

Drug: Migraine rescue medication of choice

Interventions

Treximet DRUG

Treximet

Also known as: Sumatriptan succinate 85mg/Naproxen Sodium 500mg

1

Migraine rescue medication of choice DRUG

Migraine rescue medication of choice

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and male subjects, ages 18-65 inclusive
• 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
• 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.
• Must be able to follow study protocol including all neuropsychological testing, MEWT assessments and evaluation forms.
• Must be willing and able to provide written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Neurological Research Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

The Neurological Research center, Inc

Bennington, Vermont, 05201', United States

RECRUITING

Related Publications (11)

• Ardila A, Sanchez E. Neuropsychologic symptoms in the migraine syndrome. Cephalalgia. 1988 Jun;8(2):67-70. doi: 10.1046/j.1468-2982.1988.0802067.x.

  PMID: 3401918 BACKGROUND

• Stewart WF, Lipton RB, Celentano DD, Reed ML. Prevalence of migraine headache in the United States. Relation to age, income, race, and other sociodemographic factors. JAMA. 1992 Jan 1;267(1):64-9.

  PMID: 1727198 BACKGROUND

• Palmer JE, Chronicle EP. Cognitive processing in migraine: a failure to find facilitation in patients with aura. Cephalalgia. 1998 Apr;18(3):125-32. doi: 10.1046/j.1468-2982.1998.1803125.x.

  PMID: 9595204 BACKGROUND

• Farmer K, Cady R, Bleiberg J, Reeves D. A pilot study to measure cognitive efficiency during migraine. Headache. 2000 Sep;40(8):657-61. doi: 10.1046/j.1526-4610.2000.040008657.x.

  PMID: 10971662 BACKGROUND

• Farmer K, Cady R, Bleiberg J, Reeves D, Putnam G, O'Quinn S, Batenhorst A. Sumatriptan nasal spray and cognitive function during migraine: results of an open-label study. Headache. 2001 Apr;41(4):377-84. doi: 10.1046/j.1526-4610.2001.111006377.x.

  PMID: 11318884 BACKGROUND

• 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

  BACKGROUND

• Cernich A, Reeves D, Sun W, Bleiberg J. Automated Neuropsychological Assessment Metrics sports medicine battery. Arch Clin Neuropsychol. 2007 Feb;22 Suppl 1:S101-14. doi: 10.1016/j.acn.2006.10.008. Epub 2006 Nov 21.

  PMID: 17118625 BACKGROUND

• Wilken JA, Sullivan CL, Lewandowski A, Kane RL. The use of ANAM to assess the side-effect profiles and efficacy of medication. Arch Clin Neuropsychol. 2007 Feb;22 Suppl 1:S127-33. doi: 10.1016/j.acn.2006.10.007. Epub 2006 Nov 20.

  PMID: 17116387 BACKGROUND

• Wilken JA, Kane R, Sullivan CL, Wallin M, Usiskin JB, Quig ME, Simsarian J, Saunders C, Crayton H, Mandler R, Kerr D, Reeves D, Fuchs K, Manning C, Keller M. The utility of computerized neuropsychological assessment of cognitive dysfunction in patients with relapsing-remitting multiple sclerosis. Mult Scler. 2003 Mar;9(2):119-27. doi: 10.1191/1352458503ms893oa.

  PMID: 12708806 BACKGROUND

• Roebuck-Spencer T, Sun W, Cernich AN, Farmer K, Bleiberg J. Assessing change with the Automated Neuropsychological Assessment Metrics (ANAM): issues and challenges. Arch Clin Neuropsychol. 2007 Feb;22 Suppl 1:S79-87. doi: 10.1016/j.acn.2006.10.011. Epub 2006 Nov 21.

  PMID: 17118623 BACKGROUND

• Edwards KR, Rosenthal BL, Farmer KU, Cady RK, Browning R. Evaluation of sumatriptan-naproxen in the treatment of acute migraine: a placebo-controlled, double-blind, cross-over study assessing cognitive function. Headache. 2013 Apr;53(4):656-64. doi: 10.1111/head.12052. Epub 2013 Feb 13.

  PMID: 23406052 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Cognitive Dysfunction

Interventions

sumatriptan-naproxen; Sumatriptan; Naproxen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Keith R Edwards, M.D.

  The Neurological Research Center, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith R Button, BS/CRC

CONTACT

802-447-7577; jbutton@tristateneuro.com

Carol L Gorman, LPN/CCRC

CONTACT

802-447-7577; cgorman@tristateneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 5, 2009

Record last verified: 2009-02

Locations

US (1)