Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
17 de febrero de 2021 actualizado por: Daiichi Sankyo, Inc.
A Double-Blind, Placebo-Controlled, Preliminary Study of the Efficacy, Safety, and Tolerability of Intravenous SUN N4057 in Patients With Motor Complications Associated With Parkinson's Disease
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
27
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
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California
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Fountain Valley, California, Estados Unidos, 92708
- The Parkinson's and Movement Disorder Institute
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Florida
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida, Parkinson's Disease and Movement Disorders Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30329
- Emory University--Wesley Woods Health Center
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- UMDNJ-Robert Wood Johnson Medical School
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New York
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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical Center
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Guatemala, Guatemala
- Hospital Multimedica
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Oradea, Rumania
- Hospital Clinic of Neurology and Psychiatry Oradea
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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
40 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Main Inclusion Criteria:
- Idiopathic Parkinson's disease for at least 5 years
- Presence of motor fluctuations and dyskinesia
- Stable regimen of levodopa/carbidopa for 30 days
- At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores after dosing with regular Parkinson's disease (PD) medications
- Mini-Mental State Examination (MMSE) score of 25 or higher
Main Exclusion Criteria:
- Atypical or secondary parkinsonism.
- Prior use of neuroleptic agents.
- History of intracranial procedures for PD.
- Active psychosis.
- History of drug or alcohol abuse in past 12 months.
- Cardiac conduction system abnormality.
- Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: piclozotan
Participants will be randomized to receive two 12-hour intravenous (IV) infusions of piclozotan administered at a plasma level of 30 ng/mL over 2 inpatient days.
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piclozotan, intravenous (IV) infusion
Otros nombres:
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Comparador de placebos: 0.9 % sodium chloride (normal saline)
Participants will be randomized to receive two 12-hour intravenous (IV) infusions of 0.9 % sodium chloride (normal saline) administered at a plasma level of 30 ng/mL over 2 inpatient days.
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0.9% sodium chloride (normal saline) intravenous (IV) infusion
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in the Percentage of "On" Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day-7) up to 2 days post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
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Baseline (Day-7) up to 2 days post-dose.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline up to Day 2 in the Percentage of "on" Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1, and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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Percentage of "on" Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1, and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
Negative values indicate a decrease in "on" time from baseline to measured time point.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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Percentage of "on" Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1, and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
Negative values indicate a decrease in "on" time from baseline to measured time point.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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Percentage of "on" Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1 and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
Negative values indicate a decrease in "on" time from baseline to measured time point.
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Baseline (Day -7), Day 1 and Day 2 post-dose.
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Percentage of "on" Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1 and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
Negative values indicate a decrease in "on" time from baseline to measured time point.
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Baseline (Day -7), Day 1 and Day 2 post-dose.
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Percentage of "Off" Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1, and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
Negative values indicate a decrease in "off" time from baseline to measured time point.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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Percentage of "Off" Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1, and Day 2 post-dose.
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Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
Negative values indicate a decrease in "off" time from baseline to measured time point.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Baseline (Day -7), Day 1, and Day 2 post-dose.
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The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders.
The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease.
AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome).
The total score range is 0 (better outcome) to 28 (worse outcome).
Higher scores indicate a worse outcome.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo
Periodo de tiempo: Day 1 and Day 2 post-dose.
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The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders.
The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease.
AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome).
The total score range is 0 (better outcome) to 28 (worse outcome).
Higher scores indicate a worse outcome.
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Day 1 and Day 2 post-dose.
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Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Periodo de tiempo: Day 1 pre-dose (Hour 0), 1 hour, 6 hours, 12 hours; Day 2 pre-dose (Hour 24), 1 hour (Hour 25), 6 hours (Hour 30), 12 hours (Hour 36), and Day 3 Hour 0 (Hour 48) post-dose.
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The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions.
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Day 1 pre-dose (Hour 0), 1 hour, 6 hours, 12 hours; Day 2 pre-dose (Hour 24), 1 hour (Hour 25), 6 hours (Hour 30), 12 hours (Hour 36), and Day 3 Hour 0 (Hour 48) post-dose.
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Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057
Periodo de tiempo: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
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Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
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Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
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Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057
Periodo de tiempo: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
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Cmin is the observed minimum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
Average of C24 and C48 [ie, 24 hours after the initiation of infusion on Days 1 and 2. Cmin = average of (C24 and C48)
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Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
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Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057
Periodo de tiempo: Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
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Caverage is the mean concentration of SUN N4057 in the participant blood plasma sample obtained from the observed concentrations during the 2-day drug infusions (average of C1, C6, C12, C25, C30, and C36 [ie, Hours 1, 6, 12, 25, 30, and 36 after the initiation of infusion on Day 1]).
Caverage = average of (C1, C6, C12, C25, C30, and C36)
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Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
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Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057
Periodo de tiempo: Baseline (Day 1 pre-dose) up to Hour 0, Hour 1, Hour 6, Hour 12, Hour 24, Hour 25, Hour 30, Hour 36, and Hour 48 post-dose.
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AUCt is defined as the area under the drug concentration vs time curve from zero up to the last sampling point with a quantifiable drug concentration which is above the lower limit of quantification.
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Baseline (Day 1 pre-dose) up to Hour 0, Hour 1, Hour 6, Hour 12, Hour 24, Hour 25, Hour 30, Hour 36, and Hour 48 post-dose.
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Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Periodo de tiempo: Baseline up to Day 16 post-dose, up to approximately a total 12 months.
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A treatment-emergent adverse event (TEAE) was defined as an Adverse Event (AE) that was new in onset or aggravated in severity or frequency following administration of the investigational agent.
This included any change from the screening physical examination findings or results of diagnostic procedures (eg, laboratory test, ECG) that were clinically significant, eg, required diagnostic or therapeutic intervention beyond confirmation alone.
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Baseline up to Day 16 post-dose, up to approximately a total 12 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
13 de julio de 2007
Finalización primaria (Actual)
17 de julio de 2008
Finalización del estudio (Actual)
17 de julio de 2008
Fechas de registro del estudio
Enviado por primera vez
2 de enero de 2008
Primero enviado que cumplió con los criterios de control de calidad
19 de febrero de 2008
Publicado por primera vez (Estimar)
26 de febrero de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
17 de febrero de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Enfermedad de Parkinson
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes de serotonina
- Agonistas del receptor de serotonina 5-HT1
- Agonistas del receptor de serotonina
- Piclozotan
Otros números de identificación del estudio
- ASBI-501
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Marco de tiempo para compartir IPD
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Criterios de acceso compartido de IPD
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Informe de estudio clínico (CSR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .