Pharmacogenetic Study for Topiramate-Induced Cognitive Dysfunction

• Conditions: Cognitive Dysfunction

• Registration Number: NCT00731900
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Topiramate (TPM) is an antiepileptic drug with a unique mode of action that is often useful in patients refractory to other drugs. However its use is restricted by the high incidence of cognitive adverse drug reactions (ADRs) that are associated with TPM exposure. TPM has been shown to cause particular cognitive ADRs, characterized by verbal fluency, attention, working memory and language deficits, at a much higher rate than other antiepileptic drugs. There do not appear to be obvious differences between patients that do or do not experience cognitive ADRs when on TPM (e.g. age, sex, concomitant medications, diagnosis), which suggests a genetic contributor.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-04
• Status Verified: 2008-08
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Last Update Submitted: 2008-08-08
• Study First Posted: 2008-08-11
• Last Update Posted: 2008-08-11
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• adult (>17 years old) patients with epilepsy or patients with migraine treated by topiramate

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Exclusion Criteria

• allergy to topiramate
• abnormal liver or renal function

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan