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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 100 studies in Disorders of Excessive Somnolence with a site in United States — 17 open to participants now, 20 under way, 11 of them phase 3. Disorders of Excessive Somnolence · United States.
Among the 100 studies in Disorders of Excessive Somnolence with a site in United States, this one is the 18th largest by enrollment of the 93 interventional ones that give a count, is one of 5 that started in 2017, is one of 16 in phase 2, and was the 44th registered.
196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
Browse Disorders of Excessive Somnolence studies →17 of the 100 studies in Disorders of Excessive Somnolence with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+
Alkermes, Inc. · Sites in United States
Ages 18–65
Suven Life Sciences Limited · Sites in United States
Ages 18+
Alkermes, Inc. · Sites in United States, Belgium, Canada and 2 more countries
Ages 18–70
Centessa Pharmaceuticals (UK) Limited · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
100 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 20 · Phase 3 27 · Phase 4 12
First in 1996; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 244 is above the median of 86 across 158 interventional studies indexed under Disorders of Excessive Somnolence.
Median enrollment 70 across the 93 interventional studies, 83 across the 7 observational. Of the 75 that completed or were terminated, 38 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
49 of 100 have an industry lead sponsor. The 10 most frequent:
BenevolentAI Bio is the lead sponsor of 3 studies on the registry; none are open to participants now.
BenevolentAI Bio has 1 study filed under Disorders of Excessive Somnolence — fewer than ten, so there is no comparison to draw.
11 of the studies in Disorders of Excessive Somnolence with a site in United States that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06366464Phase 3Harmony Biosciences Management, Inc.A Study of Pitolisant in Patients With Prader-Willi Syndrome | 2027-04 |
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07540897Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) | 2027-06 |
Add all 11 to your calendar (.ics) → With an account.
Among the 100 studies in Disorders of Excessive Somnolence with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in May 2019, 18 months.
Results were first posted in Nov 2020, 1 year 5 months after primary completion.
Of 15 phase 2 interventional studies under Disorders of Excessive Somnolence, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 34. This study's 18 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Disorders of Excessive Somnolence →