Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Visão geral do estudo
Status
Condições
Descrição detalhada
Lacosamide (LCM) was found in phase 3 studies to have good efficacy and tolerability as adjunctive treatment in adult patients with uncontrolled partial onset seizures, with or without secondary generalization. Dose-related adverse drug reactions (ADRs) included dizziness, headache and nausea, but the incidence of reported mood symptoms was similar to placebo. The very low incidence of such events, combined with LCM's unique mechanism of action, suggest that LCM has the potential to be among the few anti-epileptic drugs (AEDs) without clinically significant mood ADRs.
The effects of LCM on mood states (i.e., worsening or improvement) have not been examined with standardized measures. In addition, its effects on quality of life (QOL) have not been explored, although QOL is known to be affected by other AEDs.
The investigators propose to examine the effects of LCM on mood and QOL in a real-world population of adult patients with partial-onset seizures. To the knowledge of the investigators, the proposed study will be the first to examine these domains in a scientifically rigorous fashion in patients treated with LCM. Thus, study results will fill a current knowledge gap, and will provide important information to clinicians and patients when considering LCM treatment.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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New York
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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- At least 17 years old
- Have partial (focal) onset seizures that are not controlled with medication
- (LCM group only) LCM is being added to anti-epileptic drug regimen by treating physician
Exclusion Criteria:
- Have taken LCM in the past.
- Change in anti-epileptic drugs or their doses in the past 28 days.
- Have participated in another drug research study in the past 3 months.
- Have had epilepsy brain surgery, or plan to have epilepsy surgery in the next four months.
- Have a psychiatric or behavioral condition, which in the opinion of the investigator, could compromise patient's ability to participate in the study.
- Have a progressive (worsening) disease that affects patients brain and its functions.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
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LCM group
Patients who are having lacosamide (LCM) added to their anti-epileptic drug regimen
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control group
Patients who are NOT having lacosamide (LCM) added to their anti-epileptic drug regimen
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change from baseline in overall Quality of Life in Epilepsy-89 (QOLIE-89) score
Prazo: baseline and 3 months later
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baseline and 3 months later
|
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Change from baseline in Profile of Mood States (POMS) score
Prazo: baseline and 3 months later
|
baseline and 3 months later
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Change from baseline in QOLIE-89 subtests
Prazo: baseline and 3 months later
|
baseline and 3 months later
|
|
Change from baseline in POMS subtests
Prazo: baseline and 3 months later
|
baseline and 3 months later
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Arthur C Grant, MD, PhD, State University of New York - Downstate Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 11-011
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