A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
27. april 2015 oppdatert av: UCB Japan Co. Ltd.
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)
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
13
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Akita, Japan
- 191
-
Bunkyo, Japan
- 184
-
Bunkyo, Japan
- 309
-
Gifu, Japan
- 107
-
Hiroshima, Japan
- 303
-
Kobe, Japan
- 108
-
Kodaira, Japan
- 302
-
Koshi, Japan
- 306
-
Moriyama, Japan
- 136
-
Nagoya, Japan
- 305
-
Nerima, Japan
- 190
-
Neyagawa, Japan
- 125
-
Niigata, Japan
- 301
-
Ohmura, Japan
- 116
-
Okayama, Japan
- 109
-
Onojo, Japan
- 308
-
Saitama, Japan
- 119
-
Sapporo, Japan
- 117
-
Sapporo, Japan
- 304
-
Sendai, Japan
- 103
-
Shimotsuke, Japan
- 138
-
Shizuoka, Japan
- 307
-
Takatsuki, Japan
- 139
-
Tsu, Japan
- 135
-
Yokohama, Japan
- 193
-
Yufu, Japan
- 310
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 15 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Levetiracetam
To ganger daglig (morgen og kveld) oralt
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
Tidsramme: 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
Tidsramme: 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.
|
From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
|
Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
Tidsramme: 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.
|
From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
|
Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
Tidsramme: Treatment Period (Week 0 to Week 24)
|
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.
|
Treatment Period (Week 0 to Week 24)
|
|
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
Tidsramme: Evaluation Period (Week 4 to Week 24)
|
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.
|
Evaluation Period (Week 4 to Week 24)
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2011
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først innsendt
8. februar 2011
Først innsendt som oppfylte QC-kriteriene
8. februar 2011
Først lagt ut (Anslag)
10. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2015
Sist bekreftet
1. april 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- N01363
- 2014-004382-25 (EudraCT-nummer)
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