Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study

Epilepsy Clinical Trial

Official title:

Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00956696
• Other study ID #: TPM2009
• Status: Recruiting
• Phase: Phase 4
• First received: August 7, 2009
• Last updated: August 10, 2009
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2009
• Source: Chinese University of Hong Kong
• Contact: Patrick Kwan, PhD
• Phone: 9029 8234
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or above

• Patients mental retardation and with newly diagnosed epilepsy requiring treatment, or with chronic epilepsy that is unsatisfactorily controlled (defined as at least 2 seizures during an 8-week retrospective baseline).

Exclusion Criteria:

• History of nephrolithiasis or renal impairment

• Patients with absence seizures only

• History of status epilepticus in the previous 3 months while receiving appropriate antiepileptic drug therapy

• History of suicidal attempts or psychotic illness, psychiatric or mood disorders in the previous 6 months that required hospitalisation

• History of alcohol or drug abuse in the previous year

• Patients with progressive neurological conditions or terminal medical conditions.

• Patients whose seizures are thought to be of alcoholic, metabolic, neoplastic, infectious, or non-epileptic in origin (including psychogenic seizures).

• Chronic use of antacids, calcium supplements or high dose vitamin C.

• Women who are pregnant, lactating or without adequate contraception if they have child bearing potential.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• topiramate
oral, daily dose or twice daily dose, total daily dose 25-200mg per day duration: 16 weeks

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median monthly seizure frequency		16 weeks	Yes
Secondary	Responder rate		16 weeks	Yes
Secondary	SIB-R score		16 weeks	Yes
Secondary	Investigator's global evaluation scale		16 weeks	Yes
Secondary	Caregivers' global evaluation scale		16 weeks	Yes