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).
| Registry | NCT03194217, acronym CASPAR |
|---|
| Status | Completed |
|---|
| Phase | Phase 2 |
|---|
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
|---|
| Enrollment | 244 (Actual) |
|---|
| Sponsor | BenevolentAI Bio (Industry) |
|---|
| Conditions | Excessive Daytime Sleepiness, Parkinson Disease |
|---|
| Interventions | BEN-2001, Placebo (Drug) |
|---|
| Dates | start 2017-11-10, primary completion 2019-05-28, completion 2019-05-28, first posted 2017-06-21, last updated 2025-03-10 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Excessive Daytime Sleepiness All trials for Parkinson Disease All trials of BEN-2001 All trials of Placebo
-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.
Expand all sections · Collapse all
+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| BEN-2001, 0.5mg | Experimental | Drug: BEN-2001 | Experimental treatment |
| Placebo | Placebo comparator | Drug: Placebo | Placebo comparator |
| BEN-2001, 1.0mg | Experimental | Drug: BEN-2001 | Experimental treatment |
| BEN-2001, 3.0mg | Experimental | Drug: BEN-2001 | Experimental treatment |
- BEN-2001 (Drug), also known as Bavisant: Bavisant dihydrochloride monohydrate for oral use
- Placebo (Drug): Placebo
+Outcome measures
Primary outcomes
- Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. [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.
+Eligibility
Sex: All, ages: 50 Years to 80 Years
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.
+Posted results
Participant flow
| 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 |
Outcome results
- Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. (Primary), Least squares mean, units on a scale: Placebo -4.34 +/- 0.5; BEN-2001, 0.5mg -4.64 +/- 0.51; BEN-2001, 1.0mg -3.46 +/- 0.51; BEN-2001, 3.0mg -4.73 +/- 0.5 (p 0.668)
Adverse events
Time frame: 70 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Placebo | 0/60 (0.0%) | 1/60 (1.7%) | 11/60 (18.3%) |
| BEN-2001, 0.5mg | 0/60 (0.0%) | 0/60 (0.0%) | 16/60 (26.7%) |
| BEN-2001, 1.0mg | 0/60 (0.0%) | 0/60 (0.0%) | 27/60 (45.0%) |
| BEN-2001, 3.0mg | 0/64 (0.0%) | 2/64 (3.1%) | 26/64 (40.6%) |
Serious adverse events by term
| Term | Organ system | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|
| cholecystectomy | Surgical and medical procedures | 1/60 | 0/60 | 0/60 | 0/64 |
| Constipation | Gastrointestinal disorders | 0/60 | 0/60 | 0/60 | 1/64 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 0/60 | 0/60 | 0/60 | 1/64 |
Other adverse events by term
| Term | Organ system | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|
| Nasopharygitis | Infections and infestations | 3/60 | 2/60 | 1/60 | 1/64 |
| Influenza | Infections and infestations | 0/60 | 0/60 | 2/60 | 0/64 |
| Initial Insomnia | Psychiatric disorders | 2/60 | 3/60 | 1/60 | 3/64 |
| Insomnia | Psychiatric disorders | 0/60 | 0/60 | 0/60 | 3/64 |
| Middle Insomnia | Psychiatric disorders | 0/60 | 0/60 | 2/60 | 3/64 |
| Nightmare | Psychiatric disorders | 0/60 | 1/60 | 0/60 | 2/64 |
| Head ache | Nervous system disorders | 0/60 | 1/60 | 2/60 | 1/64 |
| Tremor | Nervous system disorders | 0/60 | 0/60 | 0/60 | 2/64 |
| Somnolence | Nervous system disorders | 1/60 | 0/60 | 1/60 | 2/64 |
| Cataract Nuclear | Eye disorders | 0/60 | 0/60 | 2/60 | 0/64 |
| Diarrhoea | Gastrointestinal disorders | 0/60 | 0/60 | 2/60 | 0/64 |
| Constipation | Gastrointestinal disorders | 0/60 | 0/60 | 1/60 | 2/64 |
| Abdominal Pain Upper | Gastrointestinal disorders | 0/60 | 2/60 | 0/60 | 0/64 |
| Nausea | Gastrointestinal disorders | 1/60 | 2/60 | 4/60 | 3/64 |
| Dry Mouth | Gastrointestinal disorders | 0/60 | 1/60 | 2/60 | 0/64 |
| Hyperhydrosis | Skin and subcutaneous tissue disorders | 2/60 | 1/60 | 1/60 | 1/64 |
| Back pain | Musculoskeletal and connective tissue disorders | 1/60 | 1/60 | 1/60 | 2/64 |
| Fatigue | General disorders | 0/60 | 1/60 | 2/60 | 1/64 |
| Triglycerous increase | Investigations | 1/60 | 1/60 | 3/60 | 0/64 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| MaxBlue Institute | Miami, Florida | United States | |
+Study documents
+Investigators