BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness (CASPAR)
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| ClinicalTrials.gov Identifier: NCT03194217 |
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Recruitment Status :
Recruiting
First Posted : June 21, 2017
Last Update Posted : December 4, 2017
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Sponsor:
BenevolentAI Bio
Information provided by (Responsible Party):
BenevolentAI Bio
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Excessive Daytime Sleepiness Parkinson Disease | Drug: BEN-2001 Drug: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 230 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 1, 2017 |
| Estimated Primary Completion Date : | June 30, 2018 |
| Estimated Study Completion Date : | August 31, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: BEN-2001, 0.5mg
Experimental treatment
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Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Other Name: Bavisant |
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Placebo Comparator: Placebo
Placebo comparator
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Drug: Placebo
Placebo |
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Experimental: BEN-2001, 1.0mg
Experimental treatment
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Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Other Name: Bavisant |
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Experimental: BEN-2001, 3.0mg
Experimental treatment
|
Drug: BEN-2001
Bavisant dihydrochloride monohydrate for oral use
Other Name: Bavisant |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
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
Contacts
| Contact: Peju Oshisanya | +44(0) 20 3096 0720 | clinicaltrials@benevolent.ai |
Locations
| United States, Florida | |
| MaxBlue Institute | Recruiting |
| Miami, Florida, United States, 33018 | |
| Contact: Daniel Mandri | |
Sponsors and Collaborators
BenevolentAI Bio
Investigators
| Principal Investigator: | William G Ondo, M.D | Methodist Neurological Institute |
| Responsible Party: | BenevolentAI Bio |
| ClinicalTrials.gov Identifier: | NCT03194217 History of Changes |
| Other Study ID Numbers: |
BB-2001-201b |
| First Posted: | June 21, 2017 Key Record Dates |
| Last Update Posted: | December 4, 2017 |
| Last Verified: | December 2017 |
| 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 | |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |