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Pharmacogenetic Study for Topiramate-Induced Cognitive Dysfunction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: August 7, 2008
Last updated: August 8, 2008
Last verified: August 2008
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.

Cognitive Dysfunction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 100
Study Start Date: April 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with epilepsy or patients with migraine treated by topiramate

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00731900

Contact: Horng-Huei Liou, MD;PhD 886-2-23123456 ext 8325

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Horng-Huei Liou, MD;PhD    886-2-23123456 ext 8325   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Horng-Huei Liou, MD;PhD National Taiwan University Hospital
  More Information

Responsible Party: Hrong-Huei Liou, MD;PhD, National Taiwan University Hospital Identifier: NCT00731900     History of Changes
Other Study ID Numbers: 9561707009
Study First Received: August 7, 2008
Last Updated: August 8, 2008

Keywords provided by National Taiwan University Hospital:

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders processed this record on May 25, 2017