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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731900
First Posted: August 11, 2008
Last Update Posted: August 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition
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)
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731900


Contacts
Contact: Horng-Huei Liou, MD;PhD 886-2-23123456 ext 8325 hhl@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Horng-Huei Liou, MD;PhD    886-2-23123456 ext 8325    hhl@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Horng-Huei Liou, MD;PhD National Taiwan University Hospital
  More Information

Responsible Party: Hrong-Huei Liou, MD;PhD, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00731900     History of Changes
Other Study ID Numbers: 9561707009
First Submitted: August 7, 2008
First Posted: August 11, 2008
Last Update Posted: August 11, 2008
Last Verified: August 2008

Keywords provided by National Taiwan University Hospital:
pharmacogenetic
study
Topirmate
induced

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders