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- Ensaio Clínico NCT00427011
A Study of E2007 In Patients With Parkinson's Disease
5 de fevereiro de 2013 atualizado por: Eisai Inc.
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose "Wearing-Off" Motor Fluctuations
Phase IIb open-label extension study for patients with Parkinson's Disease.
All patients will receive active study drug.
The study will involve outpatient visits only.
Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 [Visit 2] through Week 12 [Visit 7]) followed by the Maintenance Phase (from Week 12 [Visit 7] to end of study).
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
25
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Arizona
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Peoria, Arizona, Estados Unidos, 85381
- Pivotal Research Centers
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Clinical Trials Incorporated
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California
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Oxnard, California, Estados Unidos, 93030
- Pacific Neuroscience Medical Group
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
- Parkinson's Disease and Movement Disorders Center of Boca Raton
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Delray Beach, Florida, Estados Unidos, 33445
- Brain Matters Research
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Port Charlotte, Florida, Estados Unidos, 33952
- Charlotte Neurological Services
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St. Petersburg, Florida, Estados Unidos, 33701
- Suncoast Neuroscience Associates, Inc.
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27607
- Raleigh Neurology Associates
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Texas
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Lubbock, Texas, Estados Unidos, 79410
- Agape Medical Research Center, Inc.
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-
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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
INCLUSION CRITERIA
1. Male or female patients with idiopathic Parkinson's disease who have fulfilled the entry criteria for E2007-A001-214 and have completed that study up to and including the end of treatment (Day 70) visit and the Follow-up Visit at Day 91.
EXCLUSION CRITERIA
- Pregnant or lactating women.
- Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta human chorionic gonadotropin (B-HCG) test at the initial visit (Visit 1) and urine pregnancy tests throughout the study. These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of nonchildbearing potential as determined by the investigator.
- Patients who withdrew from Study 214 prior to the final efficacy visit for any reason, including lack of efficacy.
- Patients with serious adverse events in Study 214 that are either ongoing or that are possibly or probably related to the study drug.
- Patients with ongoing adverse events from Study 214 thought to be related to E2007.
- Patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
- Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment.
- Patients with a past (within 1 year) or present history of suicidal ideation or suicide attempts.
- Patients with active hepatic disease, significantly reduced hepatic function or significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range).
- Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc >= 450 msec using Fridericia's correction).
- Patients with clinically significant cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.
- Patients who are currently taking medications known to induce the enzyme cytochrome P450 3A4.
- Patients with current or prior treatment (within 4 weeks before entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel, or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine.
- Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.
- Patients receiving or with planned (next 6 months) deep brain stimulation.
- Patients with conditions affecting the peripheral or central sensory system, unless related to Parkinson's disease (such as mild sensory or pain syndromes limited to OFF periods), that could interfere with the evaluation of any such symptoms caused by the study drug.
- Patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
- Patients who have received an investigational product (other than E2007) within 4 weeks before screening.
- Patients with clinically significant cognitive impairment (mini-mental state examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
- Patients with any condition that could, in the opinion of the investigator, place the patient at increased risk or is likely to prevent completion of the study.
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: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 1
|
E2007 2mg tablets.
Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Prazo: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
|
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
This outcome measure was based on data collected through use of a patient diary.
|
Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Prazo: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
|
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
This outcome measure was based on data collected through use of a patient diary.
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Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
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Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Prazo: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD.
Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling.
Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms.
Range of possible total scores, 0 to 52.
ON state is when medication is providing benefits to mobility, slowness, and stiffness.
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
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Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
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Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Prazo: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
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The UPDRS is a standardized assessment of the symptoms and signs of Parkinson's Disease.
Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity.
Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms.
Range of possible total scores, 0 to 56.
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
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Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: David Squillacote, MD, Eisai Inc.
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 fevereiro de 2007
Conclusão Primária (Real)
1 de abril de 2008
Conclusão do estudo (Real)
1 de abril de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
24 de janeiro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de janeiro de 2007
Primeira postagem (Estimativa)
26 de janeiro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de fevereiro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de fevereiro de 2013
Última verificação
1 de fevereiro de 2013
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- E2007-A001-220
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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