Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study
Status:
Unknown status
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
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..