Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease (NCT NCT01968460)
NCT ID: NCT01968460
Last Updated: 2023-04-07
Results Overview
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
149 participants
Primary outcome timeframe
Week 12
Results posted on
2023-04-07
Participant Flow
Participant milestones
| Measure |
P2B001 Treatment A
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
50
|
|
Overall Study
COMPLETED
|
43
|
45
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Baseline characteristics by cohort
| Measure |
P2B001 Treatment A
n=49 Participants
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 Participants
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 Participants
Placebo once daily for 12 weeks.
Placebo: placebo
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
83 Participants
n=483 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 8 • n=93 Participants
|
63 years
STANDARD_DEVIATION 8 • n=4 Participants
|
64 years
STANDARD_DEVIATION 7 • n=27 Participants
|
63 years
STANDARD_DEVIATION 8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
100 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
136 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=93 Participants
|
42 participants
n=4 Participants
|
42 participants
n=27 Participants
|
126 participants
n=483 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
8 participants
n=27 Participants
|
23 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT analyis
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.
Outcome measures
| Measure |
P2B001 Treatment A
n=49 Participants
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 Participants
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 Participants
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
Total UPDRS I, II, III Scores
|
-5.97 units on a scale
Standard Error 0.94
|
-5.15 units on a scale
Standard Error 0.9
|
-1.31 units on a scale
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis
Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)
Outcome measures
| Measure |
P2B001 Treatment A
n=49 Participants
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 Participants
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 Participants
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
UPDRS ADL (Part II)
|
-1.49 units on a scale
Standard Error 0.37
|
-1.06 units on a scale
Standard Error 0.36
|
0.36 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more.
Outcome measures
| Measure |
P2B001 Treatment A
n=49 Participants
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 Participants
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 Participants
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
CGI-S
|
13 Participants
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT anlysis
Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)
Outcome measures
| Measure |
P2B001 Treatment A
n=49 Participants
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 Participants
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 Participants
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
UPDRS Motor (Part III)
|
-4.43 units on a scale
Standard Error 0.74
|
-3.95 units on a scale
Standard Error 0.7
|
-1.62 units on a scale
Standard Error 0.69
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Analysis
Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem.
Outcome measures
| Measure |
P2B001 Treatment A
n=49 Participants
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 Participants
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 Participants
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
PDQ39
|
-3.01 units on a scale
Standard Error 0.89
|
-2.19 units on a scale
Standard Error 0.88
|
0.26 units on a scale
Standard Error 0.88
|
Adverse Events
P2B001 Treatment A
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
P2B001 Treatment B
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
P2B001 Treatment A
n=49 participants at risk
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 participants at risk
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 participants at risk
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.0%
1/49 • Number of events 1 • 14 weeks
|
0.00%
0/50 • 14 weeks
|
0.00%
0/50 • 14 weeks
|
Other adverse events
| Measure |
P2B001 Treatment A
n=49 participants at risk
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
|
P2B001 Treatment B
n=50 participants at risk
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
|
Placebo
n=50 participants at risk
Placebo once daily for 12 weeks.
Placebo: placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
20.4%
10/49 • Number of events 12 • 14 weeks
|
12.0%
6/50 • Number of events 6 • 14 weeks
|
2.0%
1/50 • Number of events 1 • 14 weeks
|
|
Nervous system disorders
SOMNOLENCE
|
16.3%
8/49 • Number of events 9 • 14 weeks
|
8.0%
4/50 • Number of events 5 • 14 weeks
|
0.00%
0/50 • 14 weeks
|
|
Nervous system disorders
DIZZINESS
|
10.2%
5/49 • Number of events 6 • 14 weeks
|
4.0%
2/50 • Number of events 2 • 14 weeks
|
8.0%
4/50 • Number of events 4 • 14 weeks
|
|
General disorders
fatigue
|
8.2%
4/49 • Number of events 4 • 14 weeks
|
2.0%
1/50 • Number of events 1 • 14 weeks
|
2.0%
1/50 • Number of events 1 • 14 weeks
|
|
Infections and infestations
nasopharyngitis
|
4.1%
2/49 • Number of events 2 • 14 weeks
|
4.0%
2/50 • Number of events 2 • 14 weeks
|
10.0%
5/50 • Number of events 6 • 14 weeks
|
|
Nervous system disorders
headache
|
2.0%
1/49 • Number of events 1 • 14 weeks
|
2.0%
1/50 • Number of events 1 • 14 weeks
|
8.0%
4/50 • Number of events 4 • 14 weeks
|
|
Nervous system disorders
tremor
|
8.2%
4/49 • Number of events 5 • 14 weeks
|
6.0%
3/50 • Number of events 3 • 14 weeks
|
6.0%
3/50 • Number of events 3 • 14 weeks
|
|
Psychiatric disorders
insomnia
|
6.1%
3/49 • Number of events 3 • 14 weeks
|
0.00%
0/50 • 14 weeks
|
4.0%
2/50 • Number of events 2 • 14 weeks
|
|
Vascular disorders
orthostatic hypotension
|
4.1%
2/49 • Number of events 3 • 14 weeks
|
2.0%
1/50 • Number of events 1 • 14 weeks
|
8.0%
4/50 • Number of events 6 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place