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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194217
Recruitment Status : Completed
First Posted : June 21, 2017
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
BenevolentAI Bio

Study Description
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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.

Condition or disease Intervention/treatment Phase
Excessive Daytime Sleepiness Parkinson Disease Drug: BEN-2001 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BEN-2001, 0.5mg
Experimental treatment
 Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Other Name: Bavisant
Placebo Comparator: Placebo
Placebo comparator
 Drug: Placebo
Placebo
Experimental: BEN-2001, 1.0mg
Experimental treatment
 Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Other Name: Bavisant
Experimental: BEN-2001, 3.0mg
Experimental treatment
 Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Other Name: Bavisant


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. [ Time Frame: 6 weeks ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194217


Locations
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United States, Florida
MaxBlue Institute
Miami, Florida, United States, 33018
Sponsors and Collaborators
BenevolentAI Bio
Investigators
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Principal Investigator: William G Ondo, M.D Methodist Neurological Institute
  Study Documents (Full-Text)

Documents provided by BenevolentAI Bio:
Study Protocol  [PDF] November 7, 2018
Statistical Analysis Plan  [PDF] October 25, 2018

More Information
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Responsible Party: BenevolentAI Bio
ClinicalTrials.gov Identifier: NCT03194217    
Other Study ID Numbers: BB-2001-201b
First Posted: June 21, 2017    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Sleepiness
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases