Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
26 de fevereiro de 2014 atualizado por: Bial - Portela C S.A.
Extension Study to Investigate the Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate (BIA 2-093) in the Recurrence Prevention of Bipolar I Disorder
This was an extension study consisting of 2 parts.
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily.
Patients stable in remission continued double-blind therapy until approximately 6 months after the last patient entered Part II.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The occurrence of a new manic/depressive episode was considered a treatment failure, and the patient was discontinued from the study.
At the end of Part II, 6 months after last patient enrolled and after no longer than approximately 15 months, if patients were still in remission and the investigational product was well-tolerated, patients had the option to enter long-term open-label treatment at the same dosage as used in Part II until a new episode occurred, until marketing was authorized, or until clinical development of BIA 2-093 in the recurrence prevention indication was discontinued.
If patients did not enter long-term treatment, an established recurrence prevention medication was prescribed, and BIA 2-093 was tapered off (patients assigned to 1800 mg had the daily dose decreased to 900 mg for 6 days; those assigned to 900 mg or 300 mg received placebo for 6 days).
Tipo de estudo
Intervencional
Inscrição (Real)
104
Estágio
- Fase 2
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- signed the Informed consent form (ICF)
- completed the 3-week treatment period in Protocol with identification number SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale (YMRS) total score or a YMRS total score < 12
- presented a serum pregnancy test (in cases of women of childbearing potential) consistent with a non-gravid state and used double-barrier contraception throughout the study
Exclusion Criteria:
- relevant electrocardiogram (ECG) or laboratory abnormalities
- any uncontrolled clinically relevant disorder
- uninsured capability to comply with the study protocol
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BIA 2-093 1800 mg (Group 1)
BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily).
Study medication was administered orally, once daily in the evening.
|
BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
Outros nomes:
|
|
Experimental: BIA 2-093 900 mg (Group 2)
BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily).
Study medication was administered orally, once daily in the evening.
|
BIA 2-093 900 mg taken orally in the evening, for 2 weeks
Outros nomes:
|
|
Experimental: BIA 2-093 300 mg (Group 3)
BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily).
Study medication was administered orally, once daily in the evening.
|
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
Outros nomes:
|
|
Experimental: ESL (Part I)
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
|
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)
Prazo: 6 months
|
The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change.
The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment.
The scale for 'severity of illness' measures mania, depression and overall illness on a 7 point scale from 1 ('normal, not ill') to 7 ('very severely ill').
The scale for 'change from preceding phase' and 'change from worst phase' measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 ('not applicable').
If the patient, in 'change from preceding phase', at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.
|
6 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Patrício Soares-da-Silva, MD, PhD, BIAL - Portela & Ca. SA
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2006
Conclusão Primária (Real)
1 de junho de 2007
Conclusão do estudo (Real)
1 de junho de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
1 de abril de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de abril de 2013
Primeira postagem (Estimativa)
8 de abril de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
27 de março de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de fevereiro de 2014
Última verificação
1 de fevereiro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BIA-2093-205
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