Pharmacogenetic Study for Topiramate-Induced Cognitive Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00731900
First received: August 7, 2008
Last updated: August 8, 2008
Last verified: August 2008
  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

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014