BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Parkinson Disease Clinical Trial

— CASPAR  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194217
• Other study ID #: BB-2001-201b
• Status: Completed
• Phase: Phase 2
• Start date: November 10, 2017
• Est. completion date: May 28, 2019

Study information

• Verified date: July 2019
• Source: BenevolentAI Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Excessive Daytime Sleepiness
• Parkinson Disease
• Sleepiness

Intervention

Drug:
• BEN-2001
Bavisant dihydrochloride monohydrate for oral use
• Placebo
Placebo

Locations

Country	Name	City	State
United States	MaxBlue Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BenevolentAI Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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