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EpilepsyNCT00956696

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

An observational study of Epilepsy, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
topiramate
Type of treatment
Pill or oral medicine
How many people
50 participants
Where
1 siteHong Kong
Study dates
May 2009to Jun 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Epilepsy patients in Prince of Wales hospital.

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Patrick Kwan, PhD contact

9029 8234

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    Recruiting

Other trials in Hong Kong

About this study

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
Being tested
topiramate
Keywords
Epilepsy, mental retardation
Medical subject headings
Epilepsy, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topiramateDrug

    Also called Topamax

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

Study groups in NCT00956696
Study groupRoleWhat they receive
Topiramtesingle arm, flexible dosing
Receives: Drug: topiramate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median monthly seizure frequency

    Measured: 16 weeks

Secondary outcomes (4)
  1. Responder rate

    Measured: 16 weeks

  2. SIB-R score

    Measured: 16 weeks

  3. Investigator's global evaluation scale

    Measured: 16 weeks

  4. Caregivers' global evaluation scale

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2012 (estimated)
  4. Study completionJun 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00956696
Sponsor's protocol ID
TPM2009
Status last verified
Aug 2009
First submitted
7 Aug 2009
Last updated
11 Aug 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick Kwan, PhD (9029 8234), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median monthly seizure frequency (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.

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