Trial Outcomes & Findings for BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness (NCT NCT03194217)
NCT ID: NCT03194217
Last Updated: 2025-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo comparator
Placebo: Placebo
|
BEN-2001, 0.5mg
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 1.0mg
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 3.0mg
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
64
|
|
Overall Study
COMPLETED
|
60
|
57
|
56
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
4
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo comparator
Placebo: Placebo
|
BEN-2001, 0.5mg
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 1.0mg
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 3.0mg
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
3
|
3
|
|
Overall Study
Failure to meet randomisation criteria
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
1
|
0
|
Baseline Characteristics
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Placebo comparator
Placebo: Placebo
|
BEN-2001, 0.5mg
n=60 Participants
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 1.0mg
n=60 Participants
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 3.0mg
n=64 Participants
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
163 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
239 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
49 participants
n=5 Participants
|
53 participants
n=4 Participants
|
197 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo comparator
Placebo: Placebo
|
BEN-2001, 0.5mg
n=60 Participants
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 1.0mg
n=60 Participants
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 3.0mg
n=64 Participants
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
|---|---|---|---|---|
|
Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.
|
-4.34 units on a scale
Standard Error 0.5
|
-4.64 units on a scale
Standard Error 0.51
|
-3.46 units on a scale
Standard Error 0.51
|
-4.73 units on a scale
Standard Error 0.5
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
BEN-2001, 0.5mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
BEN-2001, 1.0mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
BEN-2001, 3.0mg
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo comparator
Placebo: Placebo
|
BEN-2001, 0.5mg
n=60 participants at risk
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 1.0mg
n=60 participants at risk
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 3.0mg
n=64 participants at risk
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
|---|---|---|---|---|
|
Surgical and medical procedures
cholecystectomy
|
1.7%
1/60 • Number of events 1 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/64 • 70 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
1.6%
1/64 • Number of events 1 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
1.6%
1/64 • Number of events 1 • 70 days
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo comparator
Placebo: Placebo
|
BEN-2001, 0.5mg
n=60 participants at risk
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 1.0mg
n=60 participants at risk
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
BEN-2001, 3.0mg
n=64 participants at risk
Experimental treatment
BEN-2001: Bavisant dihydrochloride monohydrate for oral use
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharygitis
|
5.0%
3/60 • 70 days
|
3.3%
2/60 • 70 days
|
1.7%
1/60 • 70 days
|
1.6%
1/64 • 70 days
|
|
Infections and infestations
Influenza
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
3.3%
2/60 • 70 days
|
0.00%
0/64 • 70 days
|
|
Psychiatric disorders
Initial Insomnia
|
3.3%
2/60 • 70 days
|
5.0%
3/60 • 70 days
|
1.7%
1/60 • 70 days
|
4.7%
3/64 • 70 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
4.7%
3/64 • 70 days
|
|
Psychiatric disorders
Middle Insomnia
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
3.3%
2/60 • 70 days
|
4.7%
3/64 • 70 days
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/60 • 70 days
|
1.7%
1/60 • 70 days
|
0.00%
0/60 • 70 days
|
3.1%
2/64 • 70 days
|
|
Nervous system disorders
Head ache
|
0.00%
0/60 • 70 days
|
1.7%
1/60 • 70 days
|
3.3%
2/60 • 70 days
|
1.6%
1/64 • 70 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
3.1%
2/64 • 70 days
|
|
Nervous system disorders
Somnolence
|
1.7%
1/60 • 70 days
|
0.00%
0/60 • 70 days
|
1.7%
1/60 • 70 days
|
3.1%
2/64 • 70 days
|
|
Eye disorders
Cataract Nuclear
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
3.3%
2/60 • 70 days
|
0.00%
0/64 • 70 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
3.3%
2/60 • 70 days
|
0.00%
0/64 • 70 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • 70 days
|
0.00%
0/60 • 70 days
|
1.7%
1/60 • 70 days
|
3.1%
2/64 • 70 days
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/60 • 70 days
|
3.3%
2/60 • 70 days
|
0.00%
0/60 • 70 days
|
0.00%
0/64 • 70 days
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • 70 days
|
3.3%
2/60 • 70 days
|
6.7%
4/60 • 70 days
|
4.7%
3/64 • 70 days
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/60 • 70 days
|
1.7%
1/60 • 70 days
|
3.3%
2/60 • 70 days
|
0.00%
0/64 • 70 days
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
3.3%
2/60 • 70 days
|
1.7%
1/60 • 70 days
|
1.7%
1/60 • 70 days
|
1.6%
1/64 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/60 • 70 days
|
1.7%
1/60 • 70 days
|
1.7%
1/60 • 70 days
|
3.1%
2/64 • 70 days
|
|
General disorders
Fatigue
|
0.00%
0/60 • 70 days
|
1.7%
1/60 • 70 days
|
3.3%
2/60 • 70 days
|
1.6%
1/64 • 70 days
|
|
Investigations
Triglycerous increase
|
1.7%
1/60 • 70 days
|
1.7%
1/60 • 70 days
|
5.0%
3/60 • 70 days
|
0.00%
0/64 • 70 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60