A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
27 april 2015 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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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
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 år till 15 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Levetiracetam
Två gånger dagligen (morgon och kväll) 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2011
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
8 februari 2011
Först inskickad som uppfyllde QC-kriterierna
8 februari 2011
Första postat (Uppskatta)
10 februari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N01363
- 2014-004382-25 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .