Trial Outcomes & Findings for Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients (NCT NCT00479401)
NCT ID: NCT00479401
Last Updated: 2014-07-17
Results Overview
Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
539 participants
Primary outcome timeframe
baseline and after 33 weeks treatment
Results posted on
2014-07-17
Participant Flow
Participant milestones
| Measure |
Pramipexole Extended Release (PPX ER)
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
PPX IR tablets taken three times a day
|
Placebo
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Overall Study
STARTED
|
223
|
213
|
103
|
|
Overall Study
COMPLETED
|
174
|
176
|
91
|
|
Overall Study
NOT COMPLETED
|
49
|
37
|
12
|
Reasons for withdrawal
| Measure |
Pramipexole Extended Release (PPX ER)
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
PPX IR tablets taken three times a day
|
Placebo
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
24
|
20
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
4
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
16
|
10
|
2
|
|
Overall Study
Exclusion criteria, relocation
|
4
|
3
|
0
|
Baseline Characteristics
Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
Baseline characteristics by cohort
| Measure |
Pramipexole Extended Release (PPX ER)
n=223 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=213 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
Total
n=539 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=213 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=207 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
|
-8.6 units on a scale
Interval -9.9 to -7.2
|
-8.8 units on a scale
Interval -10.2 to -7.4
|
-3.8 units on a scale
Interval -5.9 to -1.8
|
SECONDARY outcome
Timeframe: after 18 weeks of treatment compared to baselinePopulation: Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=100 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=100 Participants
PPX IR tablets taken three times a day
|
Placebo
n=50 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale
|
37 Percentage of Participants
|
48 Percentage of Participants
|
18 Percentage of Participants
|
SECONDARY outcome
Timeframe: after 18 weeks of treatment compared to baselinePopulation: Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008
Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score.
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=101 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=101 Participants
PPX IR tablets taken three times a day
|
Placebo
n=50 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale
|
35.6 Percentage of Participants
|
23.8 Percentage of Participants
|
12 Percentage of Participants
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=213 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=207 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
UPDRS II+III Responder Rate (at Least 20% Improvement)
|
68.5 percentage of responders
|
65.7 percentage of responders
|
48.5 percentage of responders
|
SECONDARY outcome
Timeframe: baseline and after 33 weeks treatmentPopulation: Full Analysis Set with (LOCF), all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=213 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=207 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
UPDRS Part I Change From Baseline
|
0.0 units on a scale
Interval -1.0 to 0.0
|
0.0 units on a scale
Interval -1.0 to 0.0
|
0.0 units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=213 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=207 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
UPDRS Part II Total Score
|
-2.2 units on a scale
Interval -2.6 to -1.7
|
-2.4 units on a scale
Interval -2.9 to -2.0
|
-0.9 units on a scale
Interval -1.5 to -0.3
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=213 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=207 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
UPDRS Part III Total Score
|
-6.4 units on a scale
Interval -7.4 to -5.4
|
-6.4 units on a scale
Interval -7.4 to -5.4
|
-2.8 units on a scale
Interval -4.2 to -1.4
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=208 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=206 Participants
PPX IR tablets taken three times a day
|
Placebo
n=102 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Beck's Depression Inventory Version I A
|
-2.0 units on a scale
Interval -2.7 to -1.3
|
-2.7 units on a scale
Interval -3.4 to -2.0
|
-2.1 units on a scale
Interval -3.1 to -1.2
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=208 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=206 Participants
PPX IR tablets taken three times a day
|
Placebo
n=102 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Likert Scale for Pain Related to PD
|
-0.2 units on a scale
Interval -0.4 to 0.1
|
-0.1 units on a scale
Interval -0.4 to 0.1
|
0.2 units on a scale
Interval -0.2 to 0.5
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=207 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=205 Participants
PPX IR tablets taken three times a day
|
Placebo
n=101 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Parkinson's Disease Sleep Scale (PDSS)
|
2.3 units on a scale
Interval -0.4 to 5.0
|
5.6 units on a scale
Interval 2.8 to 8.4
|
5.6 units on a scale
Interval 1.8 to 9.4
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include: * mobility (e.g. fear of falling when walking): 10 items * activities of daily living (e.g. difficulty cutting food): 6 items * emotional well-being (e.g. feelings of isolation): 6 items * stigma (e.g. social embarrassment): 4 items * social support: 3 items * cognition: 4 items * communication: 3 items * bodily discomfort: 3 items. A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement.
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=195 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=199 Participants
PPX IR tablets taken three times a day
|
Placebo
n=98 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score
|
-4.1 units on a scale
Interval -6.1 to -2.0
|
-6.5 units on a scale
Interval -8.6 to -4.5
|
-2.1 units on a scale
Interval -4.9 to 0.8
|
SECONDARY outcome
Timeframe: after 33 weeks treatmentPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=195 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=199 Participants
PPX IR tablets taken three times a day
|
Placebo
n=98 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life Visual Analog Scale
|
4.0 units on a scale
Interval 1.4 to 7.6
|
6.6 units on a scale
Interval 3.9 to 9.2
|
3.2 units on a scale
Interval -0.4 to 6.9
|
SECONDARY outcome
Timeframe: from trial start on to any time before final assessment of the patient, up to 33 weeksPopulation: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment
L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=213 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=207 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Patients Who Started to Use L-Dopa Rescue Medication
|
15 patients
|
9 patients
|
22 patients
|
SECONDARY outcome
Timeframe: from trial start on to any time before final assessment of the patient, up to 33 weeksPopulation: Treated Set (TS), all randomized patients, who were dispensed study medication and documented to have taken at least 1 dose of study medication.
mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=223 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=213 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)
|
4 patients
|
3 patients
|
1 patients
|
SECONDARY outcome
Timeframe: baseline and after 33 weeks of treatmentPopulation: Treated Set Labs (TSLabs), all patients in TS with a clinical laboratory measurements at baseline and at the last visit.
The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=199 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=202 Participants
PPX IR tablets taken three times a day
|
Placebo
n=99 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Haematocrit - decrease
|
4 participants
9.8
|
3 participants
10.1
|
1 participants
10.7
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Haemoglobin - decrease
|
11 participants
|
6 participants
|
1 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Red blood cell ct. - decrease
|
1 participants
|
0 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
White blood cell ct. - decrease
|
1 participants
|
0 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Neut., poly (segs) - decrease
|
2 participants
|
0 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Eosinophils - increase
|
6 participants
|
3 participants
|
3 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Neut., poly (segs), absol. - decrease
|
1 participants
|
0 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Sodium - decrease
|
5 participants
|
5 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Potassium - increase
|
3 participants
|
1 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Chloride - decrease
|
2 participants
|
0 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Alkaline phosphatase - increase
|
0 participants
|
1 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
GGT - increase
|
3 participants
|
1 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Glucose - decrease
|
3 participants
|
0 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Glucose - increase
|
1 participants
|
1 participants
|
0 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Cholesterol, total - increase
|
0 participants
|
0 participants
|
1 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Creatinine - increase
|
0 participants
|
0 participants
|
1 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Triglyceride - increase
|
9 participants
|
3 participants
|
5 participants
|
|
Possible Clinically Significant Abnormal Laboratory Parameters
Uric acid - increase
|
3 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline and after 33 weeks of treatmentPopulation: Treated set (TS)
Outcome measures
| Measure |
Pramipexole Extended Release (PPX ER)
n=223 Participants
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=213 Participants
PPX IR tablets taken three times a day
|
Placebo
n=103 Participants
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Hypertension
|
6 participants
|
7 participants
|
5 participants
|
|
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Orthostatic hypotension
|
7 participants
|
1 participants
|
1 participants
|
|
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Hypotension
|
0 participants
|
6 participants
|
1 participants
|
|
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Weight increased
|
0 participants
|
7 participants
|
0 participants
|
|
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Weight decreased
|
2 participants
|
3 participants
|
0 participants
|
|
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Blood pressure diastolic increased
|
0 participants
|
1 participants
|
0 participants
|
Adverse Events
Pramipexole Extended Release (PPX ER)
Serious events: 16 serious events
Other events: 142 other events
Deaths: 0 deaths
Pramipexole Immediate Release (PPX IR)
Serious events: 11 serious events
Other events: 133 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pramipexole Extended Release (PPX ER)
n=223 participants at risk
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=213 participants at risk
PPX IR tablets taken three times a day
|
Placebo
n=103 participants at risk
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.97%
1/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Peritonitis
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
General disorders
Fatigue
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.97%
1/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.97%
1/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.97%
1/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Investigations
Heart rate irregular
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.97%
1/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.90%
2/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Nervous system disorders
Convulsion
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Psychiatric disorders
Restlessness
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.45%
1/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.47%
1/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.00%
0/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
Other adverse events
| Measure |
Pramipexole Extended Release (PPX ER)
n=223 participants at risk
PPX ER tablets taken once in the morning
|
Pramipexole Immediate Release (PPX IR)
n=213 participants at risk
PPX IR tablets taken three times a day
|
Placebo
n=103 participants at risk
Placebo to PPX ER once and to PPX IR three times a day
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
13.9%
31/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
11.7%
25/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
1.9%
2/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
12/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
3.8%
8/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
0.97%
1/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Gastrointestinal disorders
Nausea
|
21.5%
48/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
23.9%
51/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
8.7%
9/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
General disorders
Fatigue
|
6.3%
14/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
5.2%
11/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
3.9%
4/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
General disorders
Oedema peripheral
|
5.4%
12/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
8.5%
18/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
3.9%
4/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
14/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
4.2%
9/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
7.8%
8/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
11/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
5.2%
11/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
5.8%
6/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Nervous system disorders
Dizziness
|
11.7%
26/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
11.7%
25/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
6.8%
7/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Nervous system disorders
Headache
|
3.1%
7/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
7.0%
15/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
5.8%
6/103 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
|
Nervous system disorders
Somnolence
|
36.3%
81/223 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
32.9%
70/213 • from trial start on to any time before final assessment of the patient, up to 33 weeks
|
14.6%
15/103 • from trial start on to any time before final assessment of the patient, up to 33 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