Trial Outcomes & Findings for A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients (NCT NCT00402233)
NCT ID: NCT00402233
Last Updated: 2014-05-16
Results Overview
Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
312 participants
Primary outcome timeframe
From baseline to week 12
Results posted on
2014-05-16
Participant Flow
There were 312 patients enrolled and 311 patients entered
Participant milestones
| Measure |
Placebo
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
80
|
81
|
73
|
|
Overall Study
COMPLETED
|
72
|
70
|
70
|
62
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
11
|
11
|
Reasons for withdrawal
| Measure |
Placebo
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
7
|
9
|
9
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
2
|
|
Overall Study
Worsening of disease under study
|
2
|
0
|
0
|
0
|
|
Overall Study
Worsening of other pre-existing disease
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=77 Participants
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 Participants
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 11 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
207 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 12Population: Treated set
Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)
Outcome measures
| Measure |
Placebo
n=77 Participants
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 Participants
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
UPDRS at baseline
|
28.97 units on a scale
Standard Deviation 11.82
|
27.66 units on a scale
Standard Deviation 10.72
|
27.21 units on a scale
Standard Deviation 11.76
|
27.77 units on a scale
Standard Deviation 9.18
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
UPDRS at week 12
|
28.19 units on a scale
Standard Deviation 12.94
|
22.92 units on a scale
Standard Deviation 10.44
|
22.96 units on a scale
Standard Deviation 11.94
|
22.65 units on a scale
Standard Deviation 10.82
|
SECONDARY outcome
Timeframe: From baseline to week 12Population: Treated set
Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)
Outcome measures
| Measure |
Placebo
n=77 Participants
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 Participants
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Modified Hoehn and Yahr Stage
Modified Hoehn and Yahr Stage at baseline
|
1.81 units on a scale
Standard Deviation 0.48
|
1.74 units on a scale
Standard Deviation 0.5
|
1.72 units on a scale
Standard Deviation 0.5
|
1.73 units on a scale
Standard Deviation 0.51
|
|
Modified Hoehn and Yahr Stage
Modified Hoehn and Yahr Stage at week 12
|
1.74 units on a scale
Standard Deviation 0.54
|
1.68 units on a scale
Standard Deviation 0.52
|
1.69 units on a scale
Standard Deviation 0.52
|
1.62 units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: From baseline to week 12Population: Treated set
Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Outcome measures
| Measure |
Placebo
n=77 Participants
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 Participants
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Epworth Sleepiness Scale
Epworth Sleepiness Scale at baseline
|
5.29 units on a scale
Standard Deviation 3.47
|
5.8 units on a scale
Standard Deviation 3.66
|
5.78 units on a scale
Standard Deviation 3.74
|
6.34 units on a scale
Standard Deviation 4.35
|
|
Epworth Sleepiness Scale
Epworth Sleepiness Scale at week 12
|
5.09 units on a scale
Standard Deviation 3.33
|
6.58 units on a scale
Standard Deviation 3.62
|
6.44 units on a scale
Standard Deviation 4.21
|
7.52 units on a scale
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: From baseline to week 12Population: Treated set
Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)
Outcome measures
| Measure |
Placebo
n=77 Participants
matching tablet
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 Participants
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 Participants
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Beck Depression Inventory II
Beck Depression Inventory II at baseline
|
6.05 units on a scale
Standard Deviation 6.01
|
6.66 units on a scale
Standard Deviation 5.36
|
6.96 units on a scale
Standard Deviation 5.14
|
7.4 units on a scale
Standard Deviation 5.87
|
|
Beck Depression Inventory II
Beck Depression Inventory II at week 12
|
5.92 units on a scale
Standard Deviation 5.83
|
5.70 units on a scale
Standard Deviation 5.14
|
5.97 units on a scale
Standard Deviation 5.14
|
6.54 units on a scale
Standard Deviation 5.19
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Mirapex (Pramipexole 0.5 mg Bid)
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Mirapex (Pramipexole 0.75 mg Bid)
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Mirapex (Pramipexole 0.5 mg Tid)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=77 participants at risk
matching tablet
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 participants at risk
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 participants at risk
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 participants at risk
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/77 • 12 weeks
|
0.00%
0/81 • 12 weeks
|
1.4%
1/73 • 12 weeks
|
0.00%
0/80 • 12 weeks
|
|
Nervous system disorders
Cerebral Infarction, Hemiparesis
|
0.00%
0/77 • 12 weeks
|
0.00%
0/81 • 12 weeks
|
1.4%
1/73 • 12 weeks
|
0.00%
0/80 • 12 weeks
|
|
Gastrointestinal disorders
ileus (patient stopped drugs 2 days prior)
|
0.00%
0/77 • 12 weeks
|
0.00%
0/81 • 12 weeks
|
0.00%
0/73 • 12 weeks
|
1.2%
1/80 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=77 participants at risk
matching tablet
|
Mirapex (Pramipexole 0.5 mg Bid)
n=81 participants at risk
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.75 mg Bid)
n=73 participants at risk
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
Mirapex (Pramipexole 0.5 mg Tid)
n=80 participants at risk
Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
|
|---|---|---|---|---|
|
Nervous system disorders
somnolence
|
5.2%
4/77 • 12 weeks
|
17.3%
14/81 • 12 weeks
|
21.9%
16/73 • 12 weeks
|
25.0%
20/80 • 12 weeks
|
|
Nervous system disorders
dizziness
|
9.1%
7/77 • 12 weeks
|
11.1%
9/81 • 12 weeks
|
6.8%
5/73 • 12 weeks
|
11.2%
9/80 • 12 weeks
|
|
Nervous system disorders
headache
|
10.4%
8/77 • 12 weeks
|
8.6%
7/81 • 12 weeks
|
8.2%
6/73 • 12 weeks
|
5.0%
4/80 • 12 weeks
|
|
Nervous system disorders
tremor
|
5.2%
4/77 • 12 weeks
|
1.2%
1/81 • 12 weeks
|
4.1%
3/73 • 12 weeks
|
0.00%
0/80 • 12 weeks
|
|
Gastrointestinal disorders
nausea
|
9.1%
7/77 • 12 weeks
|
22.2%
18/81 • 12 weeks
|
15.1%
11/73 • 12 weeks
|
18.8%
15/80 • 12 weeks
|
|
Gastrointestinal disorders
constipation
|
2.6%
2/77 • 12 weeks
|
9.9%
8/81 • 12 weeks
|
9.6%
7/73 • 12 weeks
|
6.2%
5/80 • 12 weeks
|
|
Psychiatric disorders
insomnia
|
5.2%
4/77 • 12 weeks
|
3.7%
3/81 • 12 weeks
|
12.3%
9/73 • 12 weeks
|
6.2%
5/80 • 12 weeks
|
|
Psychiatric disorders
abnormal dreams
|
3.9%
3/77 • 12 weeks
|
3.7%
3/81 • 12 weeks
|
2.7%
2/73 • 12 weeks
|
6.2%
5/80 • 12 weeks
|
|
General disorders
fatigue
|
3.9%
3/77 • 12 weeks
|
7.4%
6/81 • 12 weeks
|
9.6%
7/73 • 12 weeks
|
5.0%
4/80 • 12 weeks
|
|
General disorders
oedema peripheral
|
0.00%
0/77 • 12 weeks
|
2.5%
2/81 • 12 weeks
|
5.5%
4/73 • 12 weeks
|
3.8%
3/80 • 12 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER