- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00236730
A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy
6. juni 2011 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Double-Blind Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy
The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard anti-epileptic drugs.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function.
Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain.
Antiepilepsy medications, such as topiramate, are selected based on seizure type.
This is a double-blind, placebo-controlled study that includes a baseline phase and a treatment phase.
During the baseline phase (12 weeks duration), patients receive one or two of the following standard antiepileptic drugs (AEDs): phenytoin, carbamazepine, phenobarbital, or primidone.
Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase.
Patients then receive placebo or topiramate at a dosage of 100-milligrams (mg) once daily, increasing to twice daily dosing at a maximum dose of 200 mg/day, 400 mg/day, or 600 mg/day or maximum tolerated dose (depending on treatment group), through Week 16 (total duration of double-blind phase), while continuing on their standard AED regimen.
Assessments of effectiveness include the percent reduction in the average monthly seizure rate, percent of patients responding to treatment (having equal to or greater than 50% reduction in seizure rate), and, the patient's and investigator's global assessments of medication at end of study.
Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse, temperature) weekly during the treatment phase.
The study hypothesis is that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency, compared with placebo, in patients with refractory partial epilepsy and is well-tolerated.
Topiramate, 100 milligrams[mg] oral tablets.
Dosage begins at 100-mg once daily and increases gradually to twice daily dosing at a maximum dose of 200, 400, or 600 mg/day, and continues through Week 16 (total duration).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
178
Fase
- Fase 2
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 til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- History of simple or complex partial epilepsy that has been documented or witnessed
- during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs)
- and have no more than one seizure-free interval of up to 3 weeks and none longer than 3 weeks
- good physical health.
Exclusion Criteria:
- Patients having solely generalized seizures or lacking documentation of partial epilepsy
- patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
- generalized seizures, which are defined by the EEG wave pattern
- seizures that lack an abnormal pulsation pattern on EEG
- females who are capable of having children
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Procentvis reduktion i den gennemsnitlige månedlige anfaldsrate fra baseline til afslutning af behandlingen
|
Sekundære resultatmål
Resultatmål |
---|
Procent af patienter, der reagerer på behandling (>= 50 % reduktion i anfaldsfrekvens fra baseline til behandlingsslut); patientens og investigators globale vurderinger ved afslutningen af undersøgelsen; forekomst af uønskede hændelser gennem hele studiet
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. juni 1988
Studieafslutning (Faktiske)
1. december 1990
Datoer for studieregistrering
Først indsendt
7. oktober 2005
Først indsendt, der opfyldte QC-kriterier
7. oktober 2005
Først opslået (Skøn)
12. oktober 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juni 2011
Sidst verificeret
1. januar 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR005458
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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