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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01292837
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)
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Akita, Giappone
- 191
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Bunkyo, Giappone
- 184
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Bunkyo, Giappone
- 309
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Gifu, Giappone
- 107
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Hiroshima, Giappone
- 303
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Kobe, Giappone
- 108
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Kodaira, Giappone
- 302
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Koshi, Giappone
- 306
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Moriyama, Giappone
- 136
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Nagoya, Giappone
- 305
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Nerima, Giappone
- 190
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Neyagawa, Giappone
- 125
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Niigata, Giappone
- 301
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Ohmura, Giappone
- 116
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Okayama, Giappone
- 109
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Onojo, Giappone
- 308
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Saitama, Giappone
- 119
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Sapporo, Giappone
- 117
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Sapporo, Giappone
- 304
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Sendai, Giappone
- 103
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Shimotsuke, Giappone
- 138
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Shizuoka, Giappone
- 307
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Takatsuki, Giappone
- 139
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Tsu, Giappone
- 135
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Yokohama, Giappone
- 193
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Yufu, Giappone
- 310
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Levetiracetam
Due volte al giorno (mattina e sera) per via orale
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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)
Lasso di tempo: 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)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
Lasso di tempo: 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)
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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
Lasso di tempo: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
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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
Lasso di tempo: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
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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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- N01363
- 2014-004382-25 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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