Trial Outcomes & Findings for The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease (NCT NCT01470859)
NCT ID: NCT01470859
Last Updated: 2015-10-21
Results Overview
The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score). The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
twice, baseline and 1 year after baseline
Results posted on
2015-10-21
Participant Flow
Participant milestones
| Measure |
Levodopa
Sinemet Controlled Release (CR)
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Pramipexole
n=15 Participants
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
Levodopa
n=14 Participants
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.87 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 6.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: twice, baseline and 1 year after baselineThe brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score). The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.
Outcome measures
| Measure |
Levodopa
n=14 Participants
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
n=15 Participants
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Longitudinal Change of Brain Network Activity
Change from baseline (V5-V1)
|
0.41 Z-score in PDRP
Standard Deviation 0.70
|
0.61 Z-score in PDRP
Standard Deviation 0.68
|
|
Longitudinal Change of Brain Network Activity
Z score at baseline (V1)
|
2.21 Z-score in PDRP
Standard Deviation 1.54
|
3.61 Z-score in PDRP
Standard Deviation 1.77
|
|
Longitudinal Change of Brain Network Activity
Z score at 1 year (V5)
|
2.29 Z-score in PDRP
Standard Deviation 1.24
|
4.09 Z-score in PDRP
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: three times: baseline, 10 weeks, 1 yearbaseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.
Outcome measures
| Measure |
Levodopa
n=14 Participants
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
n=15 Participants
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Score (UPDRS II, III)
UPDRS II at baseline (V1)
|
7.3 units on a scale
Standard Deviation 3.5
|
7.1 units on a scale
Standard Deviation 2.9
|
|
Unified Parkinson's Disease Rating Score (UPDRS II, III)
UPDRS II (V2)
|
5.8 units on a scale
Standard Deviation 3.5
|
4.9 units on a scale
Standard Deviation 3.3
|
|
Unified Parkinson's Disease Rating Score (UPDRS II, III)
UPDRS II at 1 year (V5)
|
7.4 units on a scale
Standard Deviation 3.5
|
8.4 units on a scale
Standard Deviation 3.0
|
|
Unified Parkinson's Disease Rating Score (UPDRS II, III)
UPDRS III at baseline (V1)
|
18.7 units on a scale
Standard Deviation 7.7
|
23.1 units on a scale
Standard Deviation 10.4
|
|
Unified Parkinson's Disease Rating Score (UPDRS II, III)
UPDRS III (V2)
|
12.7 units on a scale
Standard Deviation 4.2
|
20.1 units on a scale
Standard Deviation 8.9
|
|
Unified Parkinson's Disease Rating Score (UPDRS II, III)
UPDRS III at 1 year (V5)
|
19.5 units on a scale
Standard Deviation 7.0
|
24.3 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: twice baseline and 1 yearThe PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5). PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe.
Outcome measures
| Measure |
Levodopa
n=14 Participants
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
n=15 Participants
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Parkinson's Disease Questionnaire (PDQ39)
PDQ39 at baseline (V1)
|
19.38 units on a scale
Standard Deviation 10.94
|
20.36 units on a scale
Standard Deviation 16.49
|
|
Parkinson's Disease Questionnaire (PDQ39)
PDQ39 at 1 year (V5)
|
20.36 units on a scale
Standard Deviation 16.49
|
21.07 units on a scale
Standard Deviation 12.96
|
SECONDARY outcome
Timeframe: twice baseline and 1 yearThe Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H\&Y stage range from 0-5; the greater, the more severe. The H\&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5).
Outcome measures
| Measure |
Levodopa
n=14 Participants
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
n=15 Participants
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Hoehn&Yahr (H&Y) Staging
H&Y at baseline（V1）
|
1.35 units on a scale
Standard Deviation 0.42
|
1.43 units on a scale
Standard Deviation 0.51
|
|
Hoehn&Yahr (H&Y) Staging
H&Y at 1 year（V5）
|
1.65 units on a scale
Standard Deviation 0.47
|
1.82 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: twice, at 10 weeks(V2) and 1 year(V5)Patients with a score \<= 2 (very much or much improved in relation to baseline) are considered as clinically improved. The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)
Outcome measures
| Measure |
Levodopa
n=14 Participants
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
n=15 Participants
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).
Patients with improvement at V2
|
6 participants
|
4 participants
|
|
Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).
Patients with improvement at V5
|
2 participants
|
4 participants
|
Adverse Events
Levodopa
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pramipexole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levodopa
n=14 participants at risk
Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
|
Pramipexole
n=15 participants at risk
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • 1 years
|
13.3%
2/15 • 1 years
|
|
Nervous system disorders
Insomnia
|
7.1%
1/14 • 1 years
|
0.00%
0/15 • 1 years
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • 1 years
|
0.00%
0/15 • 1 years
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14 • 1 years
|
0.00%
0/15 • 1 years
|
|
Musculoskeletal and connective tissue disorders
Courbature
|
7.1%
1/14 • 1 years
|
0.00%
0/15 • 1 years
|
Additional Information
Dr. Jian Wang
Department of Neurology, Huashan Hospital affiliated to Fudan University.
Phone: +86-13321934789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place