- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00236717
A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
6. juni 2011 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
TOPAMAX (Topiramate) Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy (RWJ-17021-000); Phase IIIB
The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age).
This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate (100 or 200mg per day) compared with standard antiepileptic drugs (carbamazepine or valproate) in patients with newly diagnosed epilepsy.
The study is composed of three phases: baseline (up to 7 days), double-blind treatment, and a blinded extension.
The double-blind phase is divided into two periods: titration, in which the dose of drug is gradually increased (approximately 35 days), and stabilization (of variable duration, with regular scheduled visits up to 92 days and then every 3 months thereafter).
The dose of study drug remains constant during the stabilization period.
In the blinded extension, patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion (patient unaware of identity of the drug).
This phase continues until the patient leaves the study or the data base for the double blind phase is finalized.
The primary assessment of effectiveness is the time to first seizure from Day 15 of the study.
Safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology and biochemistry), measurements of vital signs and body weight, and physical examination findings.
The study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated.
Oral topiramate (25milligram [mg] or 50mg capsules or tablets),starting at 25mg/day (Week 1),increasing to 100mg or 200mg/day (Week 5).Increasing carbamazepine to 600mg/day or valproate to 1250mg/day (Week 5).Maximum dosages continue for a variable time and then taper over 4 weeks to starting dose.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
865
Fase
- Fase 3
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
6 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Body weight of at least 30 kilograms
- New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry
- No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks
- Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry
Exclusion Criteria:
- Patients who do not have epilepsy
- Have progressive or degenerative disorders (for example, certain hereditary conditions)
- Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)
- Have mental retardation or other condition that could make interpretation of the study results difficult
- alcohol or drug abuse within the previous year
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 |
---|
Time to first seizure from Day 15 of the study
|
Sekundære resultatmål
Resultatmål |
---|
Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study
|
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. september 1997
Studieafslutning (Faktiske)
1. november 2000
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
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Epilepsi
- Anfald
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Beroligende midler
- Psykotropiske stoffer
- Membrantransportmodulatorer
- GABA agenter
- Antikonvulsiva
- Natriumkanalblokkere
- Antimaniske midler
- Cytokrom P-450 enzyminducere
- Cytokrom P-450 CYP3A inducere
- Valproinsyre
- Carbamazepin
- Topiramat
Andre undersøgelses-id-numre
- CR005461
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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