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

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..

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Drug: topiramate

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Epilepsy patients in Prince of Wales hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Topamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median monthly seizure frequency	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Responder rate	16 weeks
SIB-R score	16 weeks
Investigator's global evaluation scale	16 weeks
Caregivers' global evaluation scale	16 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Patrick Kwan, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: August 7, 2009
• First Submitted That Met QC Criteria: August 10, 2009
• First Posted (Estimate): August 11, 2009

Study Record Updates

• Last Update Posted (Estimate): August 11, 2009
• Last Update Submitted That Met QC Criteria: August 10, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Epilepsy; mental retardation
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Epilepsy; Learning Disabilities; Hypoglycemic Agents; Physiological Effects of Drugs; Anticonvulsants; Topiramate
• Other Study ID Numbers: TPM2009