Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE June 21, 2017
Results First Submitted Date  ICMJE September 2, 2020
Results First Posted Date  ICMJE November 24, 2020
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE November 10, 2017
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Official Title  ICMJE 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Excessive Daytime Sleepiness
  • Parkinson Disease
Intervention  ICMJE
  • Drug: BEN-2001
    Bavisant dihydrochloride monohydrate for oral use
    Other Name: Bavisant
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: BEN-2001, 0.5mg
    Experimental treatment
    Intervention: Drug: BEN-2001
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Drug: Placebo
  • Experimental: BEN-2001, 1.0mg
    Experimental treatment
    Intervention: Drug: BEN-2001
  • Experimental: BEN-2001, 3.0mg
    Experimental treatment
    Intervention: Drug: BEN-2001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2020)
244
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
230
Actual Study Completion Date  ICMJE May 28, 2019
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03194217
Other Study ID Numbers  ICMJE BB-2001-201b
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BenevolentAI Bio
Study Sponsor  ICMJE BenevolentAI Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William G Ondo, M.D Methodist Neurological Institute
PRS Account BenevolentAI Bio
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP