Status:
UNKNOWN
Treximet in Acute Migraine Headache: Assessing Cognitive Function
Lead Sponsor:
Neurological Research Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Migraine Headache
Cognitive Impairment
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Detailed Description
Overall Study Design: This study is to be a double blind crossover comparison study in patients during a migraine headache attack, with assessments at one and two hours after treatment. Patients with...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00837044
Start Date
February 1 2009
End Date
September 1 2009
Last Update
February 5 2009
Active Locations (1)
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1
The Neurological Research center, Inc
Bennington, Vermont, United States, 05201'