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A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations

28 de mayo de 2015 actualizado por: Eisai Inc.

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations

This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

75

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • Clinical Trials Incorporated
    • California
      • Oxnard, California, Estados Unidos, 93030
        • UMDNJ - Robert Wood Johnson Medical School
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Inc.
      • Delray Beach, Florida, Estados Unidos, 33445
        • Brain Matters Research
      • St. Petersburg, Florida, Estados Unidos, 33701
        • Suncoast Neuroscience Associates
    • Michigan
      • Southfield, Michigan, Estados Unidos, 48034
        • Raleigh Neurology Associates
    • New Jersey
      • Piscataway, New Jersey, Estados Unidos, 08854
        • Agape Medical Research Center
    • North Carolina
      • Raleigh, North Carolina, Estados Unidos, 27607
        • Inc.
    • Texas
      • Lubbock, Texas, Estados Unidos, 79410
        • The Clinical Neuroscience Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects of any race greater than or equal to 30 years of age
  • Have a diagnosis of idiopathic Parkinson's disease. Subjects should fulfill the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria (Queen Square criteria) and have a rating of 2 - 4 on the Hoehn and Yahr scale when in an 'off' state.
  • Receiving an optimized regimen of anti-Parkinsonian treatments that has been stable for at least four weeks before baseline. The regimen is not considered to be stable if "as required" or "on demand" dosing is routinely used or there is regular use of apomorphine or liquid forms of levodopa.
  • Taking levodopa or levodopa-containing medications (e.g. co-beneldopa, cocareldopa) at least three times daily with a good response to each levodopa dose as evidenced from patient diaries or medical notes.
  • Consistently experience end-of-dose "wearing-off" motor fluctuations. Subjects should:
  • score greater than or equal to 1 on Question 39 (What proportion of the waking day is the patient "off" on average?) of the full UPDRS at screening.
  • have at least 2.5 hours of "off" time on average per day recorded in the patient diary at baseline.
  • Willing and able to provide written informed consent and adhere to the protocol requirements, including completion of a patient diary.

Exclusion Criteria:

  • Receiving treatment with medication known to induce CYP3A4 activity
  • Previous stereotactic surgery (e.g. pallidotomy, subthalamic nucleus deep brain stimulation) for Parkinson's disease
  • Received an investigational product within four weeks prior to screening or having participated in a previous study with E2007.
  • Clinically significant cognitive impairment [mini-mental state examination (MMSE) less than 24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease].
  • 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).
  • Clinically significant ECG abnormality, including prolonged QTc (defined as QTc greater than or equal to 450 msec for males and greater than or equal to 470 msec for females using Fridericia's correction).
  • Clinically significant, cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.
  • History of drug or alcohol abuse.
  • Women who are pregnant or lactating.
  • Any condition that could, in the opinion of the investigator, place the subject at increased risk or is likely to prevent completion of the study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Any TEAE
Periodo de tiempo: Through end of study
Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.
Through end of study

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to Day 70 in "on" State of UPDRS Scores
Periodo de tiempo: Baseline and Day 70
The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the "on" and "off" state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the "on" fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease).
Baseline and Day 70
Change From Baseline to Day 70 in Absolute "Off" Time
Periodo de tiempo: Baseline and Day 70
Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.
Baseline and Day 70
Change From Baseline to Day 70 in Absolute "on" Time With Non-troublesome Dyskinesias
Periodo de tiempo: Baseline and Day 70
Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.
Baseline and Day 70
Change From Baseline to Day 70 in Absolute "on" Time With Troublesome Dyskinesias
Periodo de tiempo: Baseline and Day 70
Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.
Baseline and Day 70
Change From Baseline to Day 70 in Goetz/Rush Score
Periodo de tiempo: Baseline and Day 70
The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks.
Baseline and Day 70
Change From Baseline to Day 70 in Percent "Off" Time
Periodo de tiempo: Baseline and Day 70
Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.
Baseline and Day 70
Change From Baseline to Day 70 in Percent "on" Time
Periodo de tiempo: Baseline and Day 70
Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.
Baseline and Day 70
Change From Baseline to Day 70 in Percent "on" Time With Non-troublesome Dyskinesias
Periodo de tiempo: Baseline and Day 70
Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.
Baseline and Day 70
Disability of Dyskinesia From UPDRS at Baseline and Day 70
Periodo de tiempo: Baseline and Day 70
The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning.
Baseline and Day 70
Duration of Dyskinesia From UPDRS at Baseline and Day 70
Periodo de tiempo: Baseline and Day 70
The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning.
Baseline and Day 70

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eisai Inc.

Investigadores

  • Director de estudio: Santiago Arroyo, M.D., Ph.D, Eisai Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2005

Finalización primaria (Actual)

1 de febrero de 2006

Finalización del estudio (Actual)

1 de septiembre de 2006

Fechas de registro del estudio

Enviado por primera vez

12 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

12 de septiembre de 2005

Publicado por primera vez (Estimar)

14 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de junio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2015

Última verificación

1 de abril de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • E2007-A001-214

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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