- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00956696
Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study
10. august 2009 opdateret af: Chinese University of Hong Kong
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..
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Forventet)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Hong Kong, Hong Kong
- Rekruttering
- Prince of Wales Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Epilepsy patients in Prince of Wales hospital.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Topiramte
single arm, flexible dosing
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oral, daily dose or twice daily dose, total daily dose 25-200mg per day duration: 16 weeks
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Median monthly seizure frequency
Tidsramme: 16 weeks
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16 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Responder rate
Tidsramme: 16 weeks
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16 weeks
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SIB-R score
Tidsramme: 16 weeks
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16 weeks
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Investigator's global evaluation scale
Tidsramme: 16 weeks
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16 weeks
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Caregivers' global evaluation scale
Tidsramme: 16 weeks
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16 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Patrick Kwan, PhD, Chinese University of Hong Kong
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2009
Primær færdiggørelse (Forventet)
1. juni 2012
Studieafslutning (Forventet)
1. juni 2013
Datoer for studieregistrering
Først indsendt
7. august 2009
Først indsendt, der opfyldte QC-kriterier
10. august 2009
Først opslået (Skøn)
11. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. august 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2009
Sidst verificeret
1. august 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Neuroudviklingsforstyrrelser
- Kommunikationsforstyrrelser
- Epilepsi
- Indlæringsvanskeligheder
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Antikonvulsiva
- Topiramat
Andre undersøgelses-id-numre
- TPM2009
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