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

NCT00956696 | Unknown DMC

• 1 other identifier: TPM2009
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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..

Conditions

Epilepsy

Keywords

Epilepsy; mental retardation

Outcome Measures

Primary Outcomes (1)

• Median monthly seizure frequency

  16 weeks

Secondary Outcomes (4)

• Responder rate

  16 weeks

• SIB-R score

  16 weeks

• Investigator's global evaluation scale

  16 weeks

• Caregivers' global evaluation scale

  16 weeks

Study Arms (1)

Topiramte

single arm, flexible dosing

Drug: topiramate

Interventions

topiramate DRUG

oral, daily dose or twice daily dose, total daily dose 25-200mg per day duration: 16 weeks

Also known as: Topamax

Topiramte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Epilepsy patients in Prince of Wales hospital.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Epilepsy; Intellectual Disability

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Patrick Kwan, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Kwan, PhD

CONTACT

9029 8234

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 11, 2009

Record last verified: 2009-08

Locations

HK (1)