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| Sponsor: | Chinese University of Hong Kong |
|---|---|
| Information provided by: | Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00956696 |
Purpose
It has been estimated that 22 - 32% of people with mental retardation or learning disability have co-existing epilepsy. Despite such high prevalence and although there may be particular concerns over the effects of treatment on behaviour and cognition in this population, few studies have specifically addressed these concerns. Topiramate (TPM) is one of the modern antiepileptic drugs that has been approved for the treatment of a broad range of seizure types in both children and adults. There is evidence of associated improvement in behaviour with treatment but data is conflicting. The investigators aim to further study the effect of TPM on seizure control and behaviour using the Scales of Independent Behavior-Revised (SIB-R) which has been applied in similar patient populations and is widely adopted locally to assess the behaviour of people with mental retardation. This is a naturalistic, open label, single arm prospective study of 16-week in duration. Eligible adult patients will be initiated on TPM. Patients will be evaluated at baseline, end of weeks 4, 10 and 16. At each visit seizure control and any adverse events will be assessed. Behaviour will be assessed using SIB-R (Chinese version) at baseline and each study visit. At the end of the study period the patient's overall improvement will be rated by the investigator and the caregiver using global evaluation scales. Patients with improvement will be maintained on TPM after the end of the study period Titration schedule Topiramate will be administered orally as per usual clinical practice. Treatment will be initiated at 25 mg daily for 1 week, and increased in 25- to 50-mg increments at one- to two-weekly intervals, to an initial target dose of 100 - 200 mg daily in 2 divided doses according to each individual's response. Further dose adjustment can be made in response to further seizures or emergence of adverse events..
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: topiramate |
Phase IV |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study |
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Topiramte
single arm, flexible dosing
|
Drug: topiramate
oral, daily dose or twice daily dose, total daily dose 25-200mg per day duration: 16 weeks
Other Name: Topamax
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Epilepsy patients in Prince of Wales hospital.
Inclusion Criteria:
Patients aged 18 years or above
Exclusion Criteria:
History of nephrolithiasis or renal impairment
Contacts and Locations| Contact: Patrick Kwan, PhD | 9029 8234 |
| Hong Kong | |
| Prince of Wales Hospital | Recruiting |
| Hong Kong, Hong Kong | |
| Principal Investigator: | Patrick Kwan, PhD | Chinese University of Hong Kong |
More Information
| Responsible Party: | Dr Patrick Kwan, the Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00956696 History of Changes |
| Other Study ID Numbers: | TPM2009 |
| Study First Received: | August 7, 2009 |
| Last Updated: | August 10, 2009 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
|
Epilepsy mental retardation |
|
Epilepsy Learning Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Mental Disorders Diagnosed in Childhood |
Mental Disorders Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |