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BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness (CASPAR)

Primary Purpose

Excessive Daytime Sleepiness, Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BEN-2001
Placebo
Sponsored by
BenevolentAI Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excessive Daytime Sleepiness

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MaxBlue Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

BEN-2001, 0.5mg

Placebo

BEN-2001, 1.0mg

BEN-2001, 3.0mg

Arm Description

Experimental treatment

Placebo comparator

Experimental treatment

Experimental treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2017
Last Updated
November 3, 2020
Sponsor
BenevolentAI Bio
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1. Study Identification

Unique Protocol Identification Number
NCT03194217
Brief Title
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BenevolentAI Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Daytime Sleepiness, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BEN-2001, 0.5mg
Arm Type
Experimental
Arm Description
Experimental treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Arm Title
BEN-2001, 1.0mg
Arm Type
Experimental
Arm Description
Experimental treatment
Arm Title
BEN-2001, 3.0mg
Arm Type
Experimental
Arm Description
Experimental treatment
Intervention Type
Drug
Intervention Name(s)
BEN-2001
Other Intervention Name(s)
Bavisant
Intervention Description
Bavisant dihydrochloride monohydrate for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G Ondo, M.D
Organizational Affiliation
Methodist Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MaxBlue Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33018
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

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