Trial Outcomes & Findings for A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease (NCT NCT00256204)

Last Updated: 2012-01-12

Results Overview

The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1174 participants

Primary outcome timeframe

12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w

Results posted on

2012-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	1mg Delayed Start 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	1mg Early Start 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Delayed Start 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	2mg Early Start 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
Overall Study STARTED	298	288	295	293
Overall Study COMPLETED	231	238	241	244
Overall Study NOT COMPLETED	67	50	54	49

Reasons for withdrawal

Reasons for withdrawal
Measure	1mg Delayed Start 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	1mg Early Start 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Delayed Start 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	2mg Early Start 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
Overall Study Adverse Event	10	14	16	14
Overall Study Death	0	1	0	0
Overall Study Lost to Follow-up	1	1	1	2
Overall Study Protocol Violation	1	0	2	1
Overall Study Physician Decision	0	0	1	2
Overall Study Withdrawal by Subject	17	6	7	5
Overall Study Need for additional prohibited treatment	38	28	27	25

Baseline Characteristics

A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1mg Delayed Start n=298 Participants 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	1mg Early Start n=288 Participants 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Early Start n=293 Participants 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Delayed Start n=295 Participants 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	Total n=1174 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	175 Participants n=5 Participants	163 Participants n=7 Participants	169 Participants n=5 Participants	173 Participants n=4 Participants	680 Participants n=21 Participants
Age, Categorical >=65 years	123 Participants n=5 Participants	125 Participants n=7 Participants	124 Participants n=5 Participants	122 Participants n=4 Participants	494 Participants n=21 Participants
Age Continuous	61.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	62.4 years STANDARD_DEVIATION 9.7 • n=7 Participants	62.3 years STANDARD_DEVIATION 9.6 • n=5 Participants	62.4 years STANDARD_DEVIATION 9.7 • n=4 Participants	62.2 years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	113 Participants n=7 Participants	118 Participants n=5 Participants	113 Participants n=4 Participants	457 Participants n=21 Participants
Sex: Female, Male Male	185 Participants n=5 Participants	175 Participants n=7 Participants	175 Participants n=5 Participants	182 Participants n=4 Participants	717 Participants n=21 Participants
Region of Enrollment United States	102 participants n=5 Participants	91 participants n=7 Participants	94 participants n=5 Participants	98 participants n=4 Participants	385 participants n=21 Participants
Region of Enrollment Portugal	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	16 participants n=21 Participants
Region of Enrollment Spain	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	12 participants n=4 Participants	48 participants n=21 Participants
Region of Enrollment Austria	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	8 participants n=21 Participants
Region of Enrollment Israel	22 participants n=5 Participants	23 participants n=7 Participants	21 participants n=5 Participants	21 participants n=4 Participants	87 participants n=21 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	31 participants n=21 Participants
Region of Enrollment Italy	24 participants n=5 Participants	25 participants n=7 Participants	28 participants n=5 Participants	25 participants n=4 Participants	102 participants n=21 Participants
Region of Enrollment France	11 participants n=5 Participants	11 participants n=7 Participants	12 participants n=5 Participants	14 participants n=4 Participants	48 participants n=21 Participants
Region of Enrollment Hungary	8 participants n=5 Participants	8 participants n=7 Participants	6 participants n=5 Participants	7 participants n=4 Participants	29 participants n=21 Participants
Region of Enrollment Canada	28 participants n=5 Participants	27 participants n=7 Participants	29 participants n=5 Participants	25 participants n=4 Participants	109 participants n=21 Participants
Region of Enrollment Argentina	17 participants n=5 Participants	17 participants n=7 Participants	16 participants n=5 Participants	18 participants n=4 Participants	68 participants n=21 Participants
Region of Enrollment Romania	25 participants n=5 Participants	24 participants n=7 Participants	25 participants n=5 Participants	24 participants n=4 Participants	98 participants n=21 Participants
Region of Enrollment Germany	27 participants n=5 Participants	28 participants n=7 Participants	26 participants n=5 Participants	28 participants n=4 Participants	109 participants n=21 Participants
Region of Enrollment Netherlands	9 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	36 participants n=21 Participants

PRIMARY outcome

Timeframe: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w

Outcome measures

Outcome measures
Measure	1mg Delayed Start n=298 Participants 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	1mg Early Start n=288 Participants 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Early Start n=293 Participants 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Delayed Start n=295 Participants 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 36	3.7 Scores on a scale Standard Deviation 7.2	0.6 Scores on a scale Standard Deviation 5.9	0.8 Scores on a scale Standard Deviation 6.5	3.0 Scores on a scale Standard Deviation 6.9
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 48	1.9 Scores on a scale Standard Deviation 6.9	0.7 Scores on a scale Standard Deviation 7.0	0.5 Scores on a scale Standard Deviation 7.1	1.4 Scores on a scale Standard Deviation 6.8
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 54	1.9 Scores on a scale Standard Deviation 7.3	0.7 Scores on a scale Standard Deviation 7.1	0.8 Scores on a scale Standard Deviation 7.2	1.1 Scores on a scale Standard Deviation 7.0
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 60	1.9 Scores on a scale Standard Deviation 7.5	1.1 Scores on a scale Standard Deviation 7.3	1.2 Scores on a scale Standard Deviation 7.9	1.6 Scores on a scale Standard Deviation 7.4
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 12	0.9 Scores on a scale Standard Deviation 4.9	-1.2 Scores on a scale Standard Deviation 5.6	-0.7 Scores on a scale Standard Deviation 4.8	0.7 Scores on a scale Standard Deviation 5.6
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 24	3.0 Scores on a scale Standard Deviation 6.5	-1.1 Scores on a scale Standard Deviation 5.6	-0.5 Scores on a scale Standard Deviation 5.6	2.2 Scores on a scale Standard Deviation 6.5
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 42	2.4 Scores on a scale Standard Deviation 7.4	0.2 Scores on a scale Standard Deviation 6.7	0.4 Scores on a scale Standard Deviation 7.2	1.7 Scores on a scale Standard Deviation 6.6
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 66	2.5 Scores on a scale Standard Deviation 8.1	1.5 Scores on a scale Standard Deviation 7.7	1.5 Scores on a scale Standard Deviation 8.0	2.0 Scores on a scale Standard Deviation 8.2
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline Week 72	3.3 Scores on a scale Standard Deviation 8.9	1.9 Scores on a scale Standard Deviation 8.1	2.2 Scores on a scale Standard Deviation 8.1	2.3 Scores on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 36 weeks

Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.

Outcome measures

Outcome measures
Measure	1mg Delayed Start n=588 Participants 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)	1mg Early Start n=286 Participants 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Early Start n=290 Participants 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)	2mg Delayed Start 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase	3.9 Scores on a scale Standard Deviation 7.2	1.0 Scores on a scale Standard Deviation 6.0	0.8 Scores on a scale Standard Deviation 6.5	—

Adverse Events

Placebo Combined Group

Serious events: 22 serious events

Other events: 82 other events

Deaths: 0 deaths

1mg Active Treatment

Serious events: 37 serious events

Other events: 40 other events

Deaths: 0 deaths

2mg Active Treatment

Serious events: 44 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo Combined Group n=593 participants at risk 1mg \& 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks.	1mg Active Treatment n=288 participants at risk 1mg Active \& 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment)	2mg Active Treatment n=293 participants at risk 2mg Active \& 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment)
Musculoskeletal and connective tissue disorders Back Pain	5.4% 32/593 • Number of events 34 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.	4.9% 14/288 • Number of events 14 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.	5.1% 15/293 • Number of events 15 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.
Nervous system disorders Headache	6.2% 37/593 • Number of events 39 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.	4.9% 14/288 • Number of events 15 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.	5.1% 15/293 • Number of events 15 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.
General disorders Fatigue	2.9% 17/593 • Number of events 18 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.	5.9% 17/288 • Number of events 18 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.	3.4% 10/293 • Number of events 10 • 2 years, 6 months Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.

Additional Information

Dennis Ahern, MS, Director

Teva Branded Pharmaceutical Products R&D

Phone: 215-293-6339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Should the Oversight Committee wish to publish the results of this study, the Oversight Committee agrees to provide Teva with a manuscript for review 60 days prior to submission for publication. Teva retains the right to delete from the manuscript confidential information and to object to suggested publication and/or its timing (at the sole discretion of Teva).
Publication restrictions are in place

Restriction type: OTHER