BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Study Overview
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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.

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.

Official Title
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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).

Conditions
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Excessive Daytime Sleepiness, Parkinson Disease

Intervention / Treatment
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* Drug: BEN-2001
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEN-2001, 0.5mg<br>Experimental treatment | Drug: BEN-2001<br>* Bavisant dihydrochloride monohydrate for oral use<br>* Other names: Bavisant;|
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: Placebo<br>* Placebo<br>|
| Experimental: BEN-2001, 1.0mg<br>Experimental treatment | Drug: BEN-2001<br>* Bavisant dihydrochloride monohydrate for oral use<br>* Other names: Bavisant;|
| Experimental: BEN-2001, 3.0mg<br>Experimental treatment | Drug: BEN-2001<br>* Bavisant dihydrochloride monohydrate for oral use<br>* Other names: Bavisant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. | Mean absolute change of Bavisant treatment groups in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 6-week treatment period. The ESS score (sum of 8 item scores) ranges from 0 to 24 with higher score corresponding to higher average sleep propensity in daily life (higher daytime sleepiness). Eligibility determined based on ESS score of 13 and above. | 6 weeks |