Clinical trial NCT00956696: Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study
Official title: Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Epilepsy
mental retardation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Epilepsy patients in Prince of Wales hospital.

Brief 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..


Eligibility 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.

Primary outcomes:
measure: Median monthly seizure frequency
timeFrame: 16 weeks
Secondary outcomes:
measure: Responder rate
timeFrame: 16 weeks
measure: SIB-R score
timeFrame: 16 weeks
measure: Investigator's global evaluation scale
timeFrame: 16 weeks
measure: Caregivers' global evaluation scale
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Patrick Kwan, PhD
role: PRINCIPAL_INVESTIGATOR
References: