Excessive Daytime SleepinessPhase 2CASPARNCT03194217

BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

A Phase 2 study testing BEN-2001 in people with Excessive Daytime Sleepiness and Parkinson Disease, run by BenevolentAI Bio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Excessive Daytime Sleepiness, Parkinson Disease
What is being tested?: BEN-2001
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 244 participants
Where: 1 siteUnited States
Study dates: 10 Nov 2017to 28 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

MaxBlue Institute
Miami, Florida, 33018

Other trials in United States

About this study

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).

Read the 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.

Conditions: Excessive Daytime Sleepiness, Parkinson Disease
Being tested: BEN-2001, Placebo
Medical subject headings: Disorders of Excessive Somnolence, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BEN-2001Drug
Also called Bavisant
Bavisant dihydrochloride monohydrate for oral use
PlaceboDrug
Placebo

Study groups in NCT03194217
Study group	Role	What they receive
BEN-2001, 0.5mg	Experimental	Experimental treatment Receives: Drug: BEN-2001
Placebo	Placebo comparator	Placebo comparator Receives: Drug: Placebo
BEN-2001, 1.0mg	Experimental	Experimental treatment Receives: Drug: BEN-2001
BEN-2001, 3.0mg	Experimental	Experimental treatment Receives: Drug: BEN-2001

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Nov 201728 May 2019

First posted21 Jun 2017
Study start10 Nov 2017
Primary completion28 May 2019
Study completion28 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Excessive Daytime SleepinessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03194217
Sponsor's protocol ID: BB-2001-201b
Acronym: CASPAR
Status last verified: Feb 2025
First submitted: 19 Jun 2017
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 3
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
RecruitingPhase 2/3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2

All Excessive Daytime Sleepiness trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT03194217
Acronym / sponsor ID: CASPAR / BB-2001-201b
Conditions: Excessive Daytime Sleepiness, Parkinson Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: BenevolentAI BioIndustry (pharma, biotech, devices)
Study start: 10 Nov 2017 (actual)
Primary completion: 28 May 2019 (actual)
Study completion: 28 May 2019 (actual)
First posted: 21 Jun 2017 (actual)
Results: Posted 24 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BEN-2001, 0.5mg	Experimental	Drug: BEN-2001Experimental treatment
Placebo	Placebo comparator	Drug: PlaceboPlacebo comparator
BEN-2001, 1.0mg	Experimental	Drug: BEN-2001Experimental treatment
BEN-2001, 3.0mg	Experimental	Drug: BEN-2001Experimental treatment

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BEN-2001Also: BavisantBavisant dihydrochloride monohydrate for oral use	Drug	BEN-2001, 0.5mg, BEN-2001, 1.0mg, BEN-2001, 3.0mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 24 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	60	60
BEN-2001, 0.5mg	60	57
BEN-2001, 1.0mg	60	56
BEN-2001, 3.0mg	64	60

Primary outcome: Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.

Time frame: 6 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 60	BEN-2001, 0.5mg n = 60	BEN-2001, 1.0mg n = 60	BEN-2001, 3.0mg n = 64
Value	-4.34 (0.5)	-4.64 (0.51)	-3.46 (0.51)	-4.73 (0.5)

BEN-2001, 0.5mg: Mean Difference (Final Values): -0.30 (95% CI -1.68 to 1.08), p = 0.668, ANCOVA
BEN-2001, 1.0mg: Mean Difference (Final Values): 0.88 (95% CI -0.50 to 2.26), p = 0.213, ANCOVA
BEN-2001, 3.0mg: Mean Difference (Final Values): -0.39 (95% CI -1.76 to 0.98), p = 0.575, ANCOVA

Population analysed: ITT

Adverse events

Time frame: 70 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 60 (1.7%)	11 of 60 (18.3%)	0 of 60
BEN-2001, 0.5mg	0 of 60 (0%)	16 of 60 (26.7%)	0 of 60
BEN-2001, 1.0mg	0 of 60 (0%)	27 of 60 (45%)	0 of 60
BEN-2001, 3.0mg	2 of 64 (3.1%)	26 of 64 (40.6%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Excessive Daytime Sleepiness

RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 3
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
RecruitingPhase 2/3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William G Ondo, M.D principal investigator

Methodist Neurological Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEN-2001 in people with Excessive Daytime Sleepiness and Parkinson Disease, run by BenevolentAI Bio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.