Trial Outcomes & Findings for Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms (NCT NCT00297778)
NCT ID: NCT00297778
Last Updated: 2014-06-09
Results Overview
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
COMPLETED
PHASE4
296 participants
Baseline and Week 12
2014-06-09
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablet matching active treatment
|
Pramipexole
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
144
|
|
Overall Study
COMPLETED
|
133
|
124
|
|
Overall Study
NOT COMPLETED
|
19
|
20
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablet matching active treatment
|
Pramipexole
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Non-compliant with trial protocol
|
0
|
3
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Placebo
n=152 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=144 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
67.4 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
67 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data.
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
|
-4 Score on scale
Standard Error 0.5
|
-5.9 Score on scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Week 12Population: FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).
BDI clinical response was defined as a reduction of ≥50% from baseline
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
|
27 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.
The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
|
-1.7 units on a scale
Standard Error 0.3
|
-2.5 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.
The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
|
0 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.
The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
|
-1 units on a scale
Interval -1.0 to 0.0
|
-1 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.
Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the UPDRS Part II Total Score at Week 12
|
-1.2 units on a scale
Standard Error 0.3
|
-2.4 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.
The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=138 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the UPDRS Part III Total Score at Week 12
|
-2.2 units on a scale
Standard Error 0.5
|
-4.4 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.
The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=138 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the UPDRS Part II+III Total Score at Week 12
|
-3.4 units on a scale
Standard Error 0.7
|
-6.8 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Week 12Population: FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
|
3 units on a scale
Interval 1.0 to 6.0
|
3 units on a scale
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Outcome measures
| Measure |
Placebo
n=127 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=108 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
|
-2.4 units on a scale
Interval -8.9 to 2.6
|
-3.3 units on a scale
Interval -8.9 to 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.
This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Outcome measures
| Measure |
Placebo
n=144 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=136 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
|
0 units on a scale
Interval -0.06 to 0.12
|
0.07 units on a scale
Interval 0.0 to 0.21
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.
The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
|
-3 mm
Standard Error 1.8
|
-3.5 mm
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.
The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.
Outcome measures
| Measure |
Placebo
n=148 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=139 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the UPDRS Part I Total Score at Week 12
|
-1.0 units on a scale
Interval -1.0 to 0.0
|
-1.0 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.
The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.
Outcome measures
| Measure |
Placebo
n=137 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=131 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Change From Baseline in the UPDRS Part IV Total Score at Week 12
|
-0.2 units on a scale
Standard Error 0.1
|
-0.3 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Outcome measures
| Measure |
Placebo
n=152 Participants
Placebo tablet matching active treatment
|
Pramipexole
n=144 Participants
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Hypotension
|
1 participants
|
1 participants
|
|
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Orthostatic hypotension
|
1 participants
|
0 participants
|
Adverse Events
Placebo
Pramipexole
Serious adverse events
| Measure |
Placebo
Placebo tablet matching active treatment
|
Pramipexole
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Infections and infestations
Endocarditis
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Parkinson disease
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Radicular pain
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Syncope
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Cardiac disorders
Angina unstable
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Cardiac disorders
Cardiac failure
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Gastrointestinal disorders
Volvulus
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/152 • First drug intake up to 48 hours after the last drug intake
|
0.69%
1/144 • First drug intake up to 48 hours after the last drug intake
|
|
Injury, poisoning and procedural complications
Skull fracture base
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.66%
1/152 • First drug intake up to 48 hours after the last drug intake
|
0.00%
0/144 • First drug intake up to 48 hours after the last drug intake
|
Other adverse events
| Measure |
Placebo
Placebo tablet matching active treatment
|
Pramipexole
Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
2.6%
4/152 • First drug intake up to 48 hours after the last drug intake
|
5.6%
8/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Dizziness
|
5.9%
9/152 • First drug intake up to 48 hours after the last drug intake
|
11.1%
16/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Headache
|
7.9%
12/152 • First drug intake up to 48 hours after the last drug intake
|
11.1%
16/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Somnolence
|
7.9%
12/152 • First drug intake up to 48 hours after the last drug intake
|
10.4%
15/144 • First drug intake up to 48 hours after the last drug intake
|
|
Nervous system disorders
Dyskinesia
|
2.6%
4/152 • First drug intake up to 48 hours after the last drug intake
|
6.9%
10/144 • First drug intake up to 48 hours after the last drug intake
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
4/152 • First drug intake up to 48 hours after the last drug intake
|
6.9%
10/144 • First drug intake up to 48 hours after the last drug intake
|
|
Gastrointestinal disorders
Nausea
|
17.1%
26/152 • First drug intake up to 48 hours after the last drug intake
|
16.7%
24/144 • First drug intake up to 48 hours after the last drug intake
|
|
General disorders
Fatigue
|
5.9%
9/152 • First drug intake up to 48 hours after the last drug intake
|
5.6%
8/144 • First drug intake up to 48 hours after the last drug intake
|
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