A Phase 2 interventional study of BEN-2001 and Placebo in Excessive Daytime Sleepiness and Parkinson Disease, sponsored by BenevolentAI Bio. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by BenevolentAI Bio · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Experimental treatment
Drug: BEN-2001
Placebo comparator
Drug: Placebo
Experimental treatment
Drug: BEN-2001
Experimental treatment
Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Also known as: Bavisant
Placebo
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
| Milestone | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|---|---|---|---|
| Started | 60 | 60 | 60 | 64 |
| Completed | 60 | 57 | 56 | 60 |
| Not completed | 0 | 3 | 4 | 4 |
| Withdrew: Adverse event | 0 | 2 | 3 | 3 |
| Withdrew: Failure to meet randomisation criteria | 0 | 0 | 0 | 1 |
| Withdrew: Other | 0 | 1 | 1 | 0 |
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.
| units on a scale | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|---|---|---|---|
| Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. | -4.34 ± 0.5 | -4.64 ± 0.51 | -3.46 ± 0.51 | -4.73 ± 0.5 |
Collected over 70 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/60 (0%) | 1/60 (1.7%) | 11/60 (18.3%) |
| BEN-2001, 0.5mg | 0/60 (0%) | 0/60 (0%) | 16/60 (26.7%) |
| BEN-2001, 1.0mg | 0/60 (0%) | 0/60 (0%) | 27/60 (45%) |
| BEN-2001, 3.0mg | 0/64 (0%) | 2/64 (3.1%) | 26/64 (40.6%) |
| Event | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|---|---|---|---|
| cholecystectomySurgical and medical procedures | 1/60 | 0/60 | 0/60 | 0/64 |
| ConstipationGastrointestinal disorders | 0/60 | 0/60 | 0/60 | 1/64 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/60 | 0/60 | 0/60 | 1/64 |
| Event | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/60 | 2/60 | 4/60 | 3/64 |
| NasopharygitisInfections and infestations | 3/60 | 2/60 | 1/60 | 1/64 |
| Initial InsomniaPsychiatric disorders | 2/60 | 3/60 | 1/60 | 3/64 |
| Triglycerous increaseInvestigations | 1/60 | 1/60 | 3/60 | 0/64 |
| InsomniaPsychiatric disorders | 0/60 | 0/60 | 0/60 | 3/64 |
| Middle InsomniaPsychiatric disorders | 0/60 | 0/60 | 2/60 | 3/64 |
| InfluenzaInfections and infestations | 0/60 | 0/60 | 2/60 | 0/64 |
| Head acheNervous system disorders | 0/60 | 1/60 | 2/60 | 1/64 |
| Cataract NuclearEye disorders | 0/60 | 0/60 | 2/60 | 0/64 |
| DiarrhoeaGastrointestinal disorders | 0/60 | 0/60 | 2/60 | 0/64 |
ITT
| Age, Categorical(Participants) | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 21 | 18 | 27 | 84 |
| >=65 years | 42 | 39 | 42 | 37 | 160 |
| Sex: Female, Male(Participants) | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg | Total |
|---|---|---|---|---|---|
| Female | 21 | 23 | 17 | 20 | 81 |
| Male | 39 | 37 | 43 | 44 | 163 |
| Race (NIH/OMB)(Participants) | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 2 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 0 | 2 |
| White | 59 | 57 | 59 | 64 | 239 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg | Total |
|---|---|---|---|---|---|
| United States | 13 | 12 | 11 | 11 | 47 |
| Europe | 47 | 48 | 49 | 53 | 197 |
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