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BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

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).

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03194217
Acronym
CASPAR
Enrollment
244
Registered
2017-06-21
Start date
2017-11-10
Completion date
2019-05-28
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive Daytime Sleepiness, Parkinson Disease

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.

Interventions

DRUGBEN-2001

Bavisant dihydrochloride monohydrate for oral use

DRUGPlacebo

Placebo

Sponsors

BenevolentAI Bio
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.6 weeksMean 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo comparator Placebo: Placebo
60
BEN-2001, 0.5mg
Experimental treatment BEN-2001: Bavisant dihydrochloride monohydrate for oral use
60
BEN-2001, 1.0mg
Experimental treatment BEN-2001: Bavisant dihydrochloride monohydrate for oral use
60
BEN-2001, 3.0mg
Experimental treatment BEN-2001: Bavisant dihydrochloride monohydrate for oral use
64
Total244

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event0233
Overall StudyFailure to meet randomisation criteria0001
Overall StudyOther0110

Baseline characteristics

CharacteristicPlaceboBEN-2001, 0.5mgBEN-2001, 1.0mgBEN-2001, 3.0mgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
42 Participants39 Participants42 Participants37 Participants160 Participants
Age, Categorical
Between 18 and 65 years
18 Participants21 Participants18 Participants27 Participants84 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
59 Participants57 Participants59 Participants64 Participants239 Participants
Region of Enrollment
Europe
47 participants48 participants49 participants53 participants197 participants
Region of Enrollment
United States
13 participants12 participants11 participants11 participants47 participants
Sex: Female, Male
Female
21 Participants23 Participants17 Participants20 Participants81 Participants
Sex: Female, Male
Male
39 Participants37 Participants43 Participants44 Participants163 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 600 / 600 / 64
other
Total, other adverse events
11 / 6016 / 6027 / 6026 / 64
serious
Total, serious adverse events
1 / 600 / 600 / 602 / 64

Outcome results

Primary

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.

Time frame: 6 weeks

Population: ITT

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
PlaceboMeasurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.-4.34 units on a scaleStandard Error 0.5
BEN-2001, 0.5mgMeasurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.-4.64 units on a scaleStandard Error 0.51
BEN-2001, 1.0mgMeasurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.-3.46 units on a scaleStandard Error 0.51
BEN-2001, 3.0mgMeasurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.-4.73 units on a scaleStandard Error 0.5
p-value: 0.66895% CI: [-1.68, 1.08]ANCOVA
p-value: 0.21395% CI: [-0.5, 2.26]ANCOVA
p-value: 0.57595% CI: [-1.76, 0.98]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026