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BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness (CASPAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194217
Recruitment Status : Completed
First Posted : June 21, 2017
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
BenevolentAI Bio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Excessive Daytime Sleepiness
Parkinson Disease
Interventions Drug: BEN-2001
Drug: Placebo
Enrollment 244
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg
Hide Arm/Group Description

Placebo comparator

Placebo: Placebo

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Period Title: Overall Study
Started 60 60 60 64
Completed 60 57 56 60
Not Completed 0 3 4 4
Reason Not Completed
Adverse Event             0             2             3             3
Failure to meet randomisation criteria             0             0             0             1
Other             0             1             1             0
Arm/Group Title Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg Total
Hide Arm/Group Description

Placebo comparator

Placebo: Placebo

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Total of all reporting groups
Overall Number of Baseline Participants 60 60 60 64 244
Hide Baseline Analysis Population Description
ITT
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 64 participants 244 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  30.0%
21
  35.0%
18
  30.0%
27
  42.2%
84
  34.4%
>=65 years
42
  70.0%
39
  65.0%
42
  70.0%
37
  57.8%
160
  65.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 64 participants 244 participants
Female
21
  35.0%
23
  38.3%
17
  28.3%
20
  31.3%
81
  33.2%
Male
39
  65.0%
37
  61.7%
43
  71.7%
44
  68.8%
163
  66.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 64 participants 244 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   3.3%
0
   0.0%
0
   0.0%
2
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.7%
1
   1.7%
0
   0.0%
0
   0.0%
2
   0.8%
White
59
  98.3%
57
  95.0%
59
  98.3%
64
 100.0%
239
  98.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 64 participants 244 participants
United States 13 12 11 11 47
Europe 47 48 49 53 197
1.Primary Outcome
Title Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg
Hide Arm/Group Description:

Placebo comparator

Placebo: Placebo

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Overall Number of Participants Analyzed 60 60 60 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.34  (0.5) -4.64  (0.51) -3.46  (0.51) -4.73  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BEN-2001, 0.5mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-1.68 to 1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BEN-2001, 1.0mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
-0.50 to 2.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BEN-2001, 3.0mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-1.76 to 0.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
Time Frame 70 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg
Hide Arm/Group Description

Placebo comparator

Placebo: Placebo

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

Experimental treatment

BEN-2001: Bavisant dihydrochloride monohydrate for oral use

All-Cause Mortality
Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      0/60 (0.00%)      0/60 (0.00%)      0/64 (0.00%)    
Hide Serious Adverse Events
Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/60 (1.67%)      0/60 (0.00%)      0/60 (0.00%)      2/64 (3.13%)    
Gastrointestinal disorders         
Constipation  1  0/60 (0.00%)  0 0/60 (0.00%)  0 0/60 (0.00%)  0 1/64 (1.56%)  1
Musculoskeletal and connective tissue disorders         
Muscular weakness  1  0/60 (0.00%)  0 0/60 (0.00%)  0 0/60 (0.00%)  0 1/64 (1.56%)  1
Surgical and medical procedures         
cholecystectomy  1  1/60 (1.67%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0 0/64 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo BEN-2001, 0.5mg BEN-2001, 1.0mg BEN-2001, 3.0mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/60 (18.33%)      16/60 (26.67%)      27/60 (45.00%)      26/64 (40.63%)    
Eye disorders         
Cataract Nuclear  1  0/60 (0.00%)  0/60 (0.00%)  2/60 (3.33%)  0/64 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  0/60 (0.00%)  0/60 (0.00%)  2/60 (3.33%)  0/64 (0.00%) 
Constipation  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%)  2/64 (3.13%) 
Abdominal Pain Upper  1  0/60 (0.00%)  2/60 (3.33%)  0/60 (0.00%)  0/64 (0.00%) 
Nausea  1  1/60 (1.67%)  2/60 (3.33%)  4/60 (6.67%)  3/64 (4.69%) 
Dry Mouth  1  0/60 (0.00%)  1/60 (1.67%)  2/60 (3.33%)  0/64 (0.00%) 
General disorders         
Fatigue  1  0/60 (0.00%)  1/60 (1.67%)  2/60 (3.33%)  1/64 (1.56%) 
Infections and infestations         
Nasopharygitis  1  3/60 (5.00%)  2/60 (3.33%)  1/60 (1.67%)  1/64 (1.56%) 
Influenza  1  0/60 (0.00%)  0/60 (0.00%)  2/60 (3.33%)  0/64 (0.00%) 
Investigations         
Triglycerous increase  1  1/60 (1.67%)  1/60 (1.67%)  3/60 (5.00%)  0/64 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/60 (1.67%)  1/60 (1.67%)  1/60 (1.67%)  2/64 (3.13%) 
Nervous system disorders         
Head ache  1  0/60 (0.00%)  1/60 (1.67%)  2/60 (3.33%)  1/64 (1.56%) 
Tremor  1  0/60 (0.00%)  0/60 (0.00%)  0/60 (0.00%)  2/64 (3.13%) 
Somnolence  1  1/60 (1.67%)  0/60 (0.00%)  1/60 (1.67%)  2/64 (3.13%) 
Psychiatric disorders         
Initial Insomnia  1  2/60 (3.33%)  3/60 (5.00%)  1/60 (1.67%)  3/64 (4.69%) 
Insomnia  1  0/60 (0.00%)  0/60 (0.00%)  0/60 (0.00%)  3/64 (4.69%) 
Middle Insomnia  1  0/60 (0.00%)  0/60 (0.00%)  2/60 (3.33%)  3/64 (4.69%) 
Nightmare  1  0/60 (0.00%)  1/60 (1.67%)  0/60 (0.00%)  2/64 (3.13%) 
Skin and subcutaneous tissue disorders         
Hyperhydrosis  1  2/60 (3.33%)  1/60 (1.67%)  1/60 (1.67%)  1/64 (1.56%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne Phelan
Organization: BenevolentAI
Phone: +44 20 3781 9360
EMail: anne.phelan@benevolent.ai
Layout table for additonal information
Responsible Party: BenevolentAI Bio
ClinicalTrials.gov Identifier: NCT03194217    
Other Study ID Numbers: BB-2001-201b
First Submitted: June 19, 2017
First Posted: June 21, 2017
Results First Submitted: September 2, 2020
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020