Pharmacogenetic Study for Topiramate-Induced Cognitive Dysfunction

Cognitive Dysfunction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00731900
• Other study ID #: 9561707009
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2008
• Last updated: August 8, 2008
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: National Taiwan University Hospital
• Contact: Horng-Huei Liou, MD;PhD
• Phone: 886-2-23123456
• Email: hhl[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• allergy to topiramate

• abnormal liver or renal function

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,