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临床试验/NCT00956696
NCT00956696Unknown不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Median monthly seizure frequency

研究概览

简要总结

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..

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Topiramte

single arm, flexible dosing

干预措施: topiramate (Drug)

结局指标

主要结局

Median monthly seizure frequency

时间窗: 16 weeks

次要结局

  • Responder rate(16 weeks)
  • SIB-R score(16 weeks)
  • Investigator's global evaluation scale(16 weeks)
  • Caregivers' global evaluation scale(16 weeks)

研究者

申办方类型
Other

研究点 (1)

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