BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).

Patrocinadores

Patrocinador principal: BenevolentAI Bio

Fuente BenevolentAI Bio
Resumen breve

This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.

Descripción detallada

Phase 2b study will be conducted with the aim of investigating the efficacy and safety of three fixed doses of Bavisant (0.5, 1 and 3 mg/d) compared to placebo for the treatment of excessive daytime sleepiness (EDS) in subjects with Parkinson's disease.

Estado general Completed
Fecha de inicio November 10, 2017
Fecha de Terminación May 28, 2019
Fecha de finalización primaria May 28, 2019
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Measurement of sleepiness using the Epworth Sleepiness Scale (ESS) at baseline and post dose. 6 weeks
Inscripción 248
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: BEN-2001

Descripción: Bavisant dihydrochloride monohydrate for oral use

Otro nombre: Bavisant

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: Placebo

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

Inclusion Criteria:

- Subjects of either sex aged 50 to 80 years *Subjects with previous diagnosis of Parkinson's disease (following the UK Parkinson's disease society brain bank clinical diagnostic criteria)*

- Subjects capable of understanding and complying with protocol requirements

- Subjects with medical history of excessive daytime sleepiness

Exclusion Criteria:

- Subjects with excessive daytime sleepiness due to conditions other than Parkinson's disease (including narcolepsy)

- Subjects with clinical evidence of depression with significant psychiatric comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or equal to 17; with or without treatment)

- Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater than or equal to 36

- Subjects with known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.

- Subjects with known allergies or hypersensitivity to Bavisant or any of its excipients.

- Subjects who are pregnant or lactating.

Género: All

Edad mínima: 50 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
William G Ondo, M.D Principal Investigator Methodist Neurological Institute
Ubicación
Instalaciones: MaxBlue Institute
Ubicacion Paises

United States

Fecha de verificación

July 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: BEN-2001, 0.5mg

Tipo: Experimental

Descripción: Experimental treatment

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Placebo comparator

Etiqueta: BEN-2001, 1.0mg

Tipo: Experimental

Descripción: Experimental treatment

Etiqueta: BEN-2001, 3.0mg

Tipo: Experimental

Descripción: Experimental treatment

Acrónimo CASPAR
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov