BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness (CASPAR)
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ClinicalTrials.gov Identifier: NCT03194217 |
Recruitment Status :
Completed
First Posted : June 21, 2017
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Excessive Daytime Sleepiness Parkinson Disease | Drug: BEN-2001 Drug: Placebo | Phase 2 |
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 |

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 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Florida | |
MaxBlue Institute | |
Miami, Florida, United States, 33018 |
Principal Investigator: | William G Ondo, M.D | Methodist Neurological Institute |
Documents provided by BenevolentAI Bio:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Disorders of Excessive Somnolence Sleepiness Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Movement Disorders Synucleinopathies Neurodegenerative Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Mental Disorders |