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Pharmacogenetic Study for Topiramate-Induced Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT00731900
Recruitment Status : Unknown
Verified August 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 11, 2008
Last Update Posted : August 11, 2008
Sponsor:
Information provided by:
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.

Condition or disease
Cognitive Dysfunction

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : April 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009




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

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

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