BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2019-05-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Excessive Daytime Sleepiness Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BEN-2001, 0.5mg

Experimental treatment

Group Type EXPERIMENTAL

BEN-2001

Intervention Type DRUG

Bavisant dihydrochloride monohydrate for oral use

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

BEN-2001, 1.0mg

Experimental treatment

Group Type EXPERIMENTAL

BEN-2001

Intervention Type DRUG

Bavisant dihydrochloride monohydrate for oral use

BEN-2001, 3.0mg

Experimental treatment

Group Type EXPERIMENTAL

BEN-2001

Intervention Type DRUG

Bavisant dihydrochloride monohydrate for oral use

Interventions

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BEN-2001

Bavisant dihydrochloride monohydrate for oral use

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Bavisant

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No