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A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Akita, Japan
- 191
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Bunkyo, Japan
- 184
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Bunkyo, Japan
- 309
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Gifu, Japan
- 107
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Hiroshima, Japan
- 303
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Kobe, Japan
- 108
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Kodaira, Japan
- 302
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Koshi, Japan
- 306
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Moriyama, Japan
- 136
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Nagoya, Japan
- 305
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Nerima, Japan
- 190
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Neyagawa, Japan
- 125
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Niigata, Japan
- 301
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Ohmura, Japan
- 116
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Okayama, Japan
- 109
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Onojo, Japan
- 308
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Saitama, Japan
- 119
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Sapporo, Japan
- 117
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Sapporo, Japan
- 304
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Sendai, Japan
- 103
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Shimotsuke, Japan
- 138
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Shizuoka, Japan
- 307
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Takatsuki, Japan
- 139
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Tsu, Japan
- 135
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Yokohama, Japan
- 193
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Yufu, Japan
- 310
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
- A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period
Exclusion Criteria:
- Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
- Diagnosis of Lennox-Gastaut Syndrome
- Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
- A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Levetiracetam
Tweemaal daags ('s ochtends en 's avonds) oraal innemen
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The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks.
After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
Tijdsspanne: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below. The percent change from Baseline = (B - T)/B x 100 The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7 |
From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
Tijdsspanne: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below. The percent change from Baseline = (B - E)/B x 100 The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7 |
From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
Tijdsspanne: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
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From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
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Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
Tijdsspanne: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
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From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
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Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
Tijdsspanne: Treatment Period (Week 0 to Week 24)
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A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
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Treatment Period (Week 0 to Week 24)
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Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
Tijdsspanne: Evaluation Period (Week 4 to Week 24)
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A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.
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Evaluation Period (Week 4 to Week 24)
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- N01363
- 2014-004382-25 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Levetiracetam
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UCB Pharma SAVoltooid
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Johns Hopkins UniversityNational Institute on Aging (NIA)VoltooidMilde cognitieve stoornis (MCI)Verenigde Staten
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Richard H. HaasThrasher Research FundVoltooidAanvallen | Aandoening van foetus of pasgeboreneVerenigde Staten
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UCB Japan Co. Ltd.VoltooidEpilepsie, gedeeltelijkJapan
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Odense University HospitalVoltooid
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Odense University HospitalVoltooid
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Oslo University HospitalOnbekendSubklinische door slaap geactiveerde epileptische activiteit | CSWSNoorwegen
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National Institute of Mental Health (NIMH)VoltooidBipolaire stoornisVerenigde Staten
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UCB PharmaParexelVoltooidGezonde onderwerpen | NierstoornissenJapan
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Johns Hopkins UniversityAgeneBioWervingPsychose van de ziekte van ParkinsonVerenigde Staten