Trial Outcomes & Findings for Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment (NCT NCT00651183)
NCT ID: NCT00651183
Last Updated: 2014-05-20
Results Overview
Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score
COMPLETED
286 participants
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
2014-05-20
Participant Flow
Participant milestones
| Measure |
Early (PD)
Early Parkinson's Disease (PD) patients
|
Advanced PD
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
97
|
|
Overall Study
COMPLETED
|
169
|
87
|
|
Overall Study
NOT COMPLETED
|
20
|
10
|
Reasons for withdrawal
| Measure |
Early (PD)
Early Parkinson's Disease (PD) patients
|
Advanced PD
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Efficacy insufficient + patients wish
|
0
|
1
|
|
Overall Study
Tolerability insufficient
|
5
|
2
|
|
Overall Study
Tolerability insufficient +Patients wish
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Other reasons
|
4
|
2
|
|
Overall Study
missing
|
1
|
0
|
Baseline Characteristics
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
Baseline characteristics by cohort
| Measure |
Early PD
n=189 Participants
Early Parkinson's Disease (PD) patients
|
Advanced PD
n=97 Participants
Advanced Parkinson's Disease (PD) patients
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 6.97 • n=7 Participants
|
70.6 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
80 participants
n=5 Participants
|
35 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
108 participants
n=5 Participants
|
61 participants
n=7 Participants
|
169 participants
n=5 Participants
|
|
Sex/Gender, Customized
missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)Population: Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis
Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score
Outcome measures
| Measure |
Early PD
n=165 Participants
Early Parkinson's Disease (PD) patients
|
Advanced PD
n=85 Participants
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
|
2 Points on a scale
Interval 1.0 to 3.0
|
2 Points on a scale
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)Population: Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Outcome measures
| Measure |
Early PD
n=161 Participants
Early Parkinson's Disease (PD) patients
|
Advanced PD
n=79 Participants
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
|
3 Points on a scale
Interval 1.0 to 6.0
|
4 Points on a scale
Interval 2.0 to 7.0
|
PRIMARY outcome
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)Population: Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Outcome measures
| Measure |
Early PD
n=161 Participants
Early Parkinson's Disease (PD) patients
|
Advanced PD
n=79 Participants
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
|
2 Points on a scale
Interval 1.0 to 4.0
|
4 Points on a scale
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)Population: Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis
14 components rating scale with 27 items scored by 0 (none) - 4 (severe)
Outcome measures
| Measure |
Early PD
n=172 Participants
Early Parkinson's Disease (PD) patients
|
Advanced PD
n=87 Participants
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Change From Baseline in UPDRS Part III (Motor Examination)
|
9 Points on a scale
Interval 4.0 to 14.0
|
10 Points on a scale
Interval 6.0 to 17.0
|
Adverse Events
Early PD
Advanced PD
Serious adverse events
| Measure |
Early PD
n=189 participants at risk
Early Parkinson's Disease (PD) patients
|
Advanced PD
n=97 participants at risk
Advanced Parkinson's Disease (PD) patients
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/189 • Up to 16 weeks
The safety analysis set (SAF) includes the data of all 286 patients (189 early PD patients/ 97 advanced PD patients - reported to have received at least one dose of study drug, i.e. pramipexole
|
1.0%
1/97 • Up to 16 weeks
The safety analysis set (SAF) includes the data of all 286 patients (189 early PD patients/ 97 advanced PD patients - reported to have received at least one dose of study drug, i.e. pramipexole
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
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