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

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ClinicalTrials.gov Identifier: NCT03194217
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
BenevolentAI Bio

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 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 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


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




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.



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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.

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


Contacts
Contact: Peju Oshisanya +44(0) 20 3096 0720 clinicaltrials@benevolent.ai

Locations
United States, Florida
MaxBlue Institute Recruiting
Miami, Florida, United States, 33018
Contact: Daniel Mandri         
Sponsors and Collaborators
BenevolentAI Bio
Investigators
Principal Investigator: William G Ondo, M.D Methodist Neurological Institute

Responsible Party: BenevolentAI Bio
ClinicalTrials.gov Identifier: NCT03194217     History of Changes
Other Study ID Numbers: BB-2001-201b
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases