Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study
Information source: Chinese University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: topiramate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Chinese University of Hong Kong Official(s) and/or principal investigator(s): Patrick Kwan, PhD, Principal Investigator, Affiliation: Chinese University of Hong Kong
Overall contact: Patrick Kwan, PhD, Phone: 9029 8234
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..
Clinical Details
Official title: Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Median monthly seizure frequency
Secondary outcome: Responder rateSIB-R score Investigator's global evaluation scale Caregivers' global evaluation scale
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Patrick Kwan, PhD, Phone: 9029 8234
Prince of Wales Hospital, Hong Kong, Hong Kong; Recruiting
Additional Information
Starting date: May 2009
Last updated: August 10, 2009
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