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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00956696
First received: August 7, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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..


Condition Intervention Phase
Epilepsy
Drug: topiramate
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Median monthly seizure frequency [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Responder rate [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • SIB-R score [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Investigator's global evaluation scale [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Caregivers' global evaluation scale [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Topamax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Epilepsy patients in Prince of Wales hospital.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956696

Contacts
Contact: Patrick Kwan, PhD 9029 8234

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Patrick Kwan, PhD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr Patrick Kwan, the Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00956696     History of Changes
Other Study ID Numbers: TPM2009
Study First Received: August 7, 2009
Last Updated: August 10, 2009
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Epilepsy
mental retardation

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on September 18, 2014