Trial Outcomes & Findings for Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole (NCT NCT00615914)
NCT ID: NCT00615914
Last Updated: 2014-07-11
Results Overview
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.
Recruitment status
COMPLETED
Target enrollment
1645 participants
Primary outcome timeframe
during 18 months
Results posted on
2014-07-11
Participant Flow
Participant milestones
| Measure |
Pramipexole
Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
|
|---|---|
|
Overall Study
STARTED
|
1645
|
|
Overall Study
COMPLETED
|
1008
|
|
Overall Study
NOT COMPLETED
|
637
|
Reasons for withdrawal
| Measure |
Pramipexole
Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
|
|---|---|
|
Overall Study
Adverse Event
|
274
|
|
Overall Study
Death
|
20
|
|
Overall Study
Lack of Efficacy
|
59
|
|
Overall Study
Lost to Follow-up
|
187
|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
No data was collected.
|
65
|
|
Overall Study
No treatment
|
2
|
|
Overall Study
Irregularly enrolled patients
|
10
|
Baseline Characteristics
Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
Baseline characteristics by cohort
| Measure |
Pramipexole
n=1553 Participants
Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
890 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
663 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during 18 monthsPopulation: Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.
Outcome measures
| Measure |
Pramipexole
n=1553 Participants
The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Proportion of Adverse Events
|
42.4 percentage of participants
|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Proportion of Adverse Drug Reactions
|
34.5 percentage of participants
|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Proportion of Serious Adverse Events
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.
Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Outcome measures
| Measure |
Pramipexole
n=1527 Participants
The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Clinical Global Impression of Improvement
Very much improved
|
48 Participants
|
|
Clinical Global Impression of Improvement
Much improved
|
561 Participants
|
|
Clinical Global Impression of Improvement
Minimally improved
|
484 Participants
|
|
Clinical Global Impression of Improvement
No effect
|
209 Participants
|
|
Clinical Global Impression of Improvement
Unassessable
|
225 Participants
|
SECONDARY outcome
Timeframe: Baseline and at 18 months (or at the time of discontinuation)Population: The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Outcome measures
| Measure |
Pramipexole
n=1356 Participants
The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
|
-5.4 Unit on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline and at 18 months (or at the time of discontinuation)Population: The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn \& Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).
A severity of PD symptom are assessed by Modified Hoehn \& Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
Outcome measures
| Measure |
Pramipexole
n=1430 Participants
The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Change From Baseline in Modified Hoehn & Yahr Rating Scale
|
-0.2 Unit on a scale
Standard Deviation 0.6
|
Adverse Events
Pramipexole
Serious events: 111 serious events
Other events: 267 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pramipexole
n=1553 participants at risk
Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Infections and infestations
Influenza
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Infections and infestations
Pneumonia
|
1.0%
16/1553 • Number of events 16 • 18 months
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Infections and infestations
Pyothorax
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Psychiatric disorders
Agitation
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Psychiatric disorders
Confusional state
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Psychiatric disorders
Delirium
|
0.45%
7/1553 • Number of events 7 • 18 months
|
|
Psychiatric disorders
Delusion
|
0.39%
6/1553 • Number of events 6 • 18 months
|
|
Psychiatric disorders
Hallucination
|
0.45%
7/1553 • Number of events 7 • 18 months
|
|
Psychiatric disorders
Hallucination, auditory
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Persecutory delusion
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Suicide attempt
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Bipolar disorder
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Brain stem infarction
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Nervous system disorders
Coma hepatic
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Convulsion
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Nervous system disorders
Dizziness
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Nervous system disorders
Headache
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Nervous system disorders
Somnolence
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Sudden onset of sleep
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Nervous system disorders
Cerebral haematoma
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Putamen haemorrhage
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Angina pectoris
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Cardiac failure
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Sick sinus syndrome
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Vascular disorders
Shock
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.26%
4/1553 • Number of events 4 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.32%
5/1553 • Number of events 5 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Volvulus
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Hepatobiliary disorders
Liver disorder
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Renal and urinary disorders
Crush syndrome
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
General disorders
Chest pain
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
General disorders
Death
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
General disorders
Drowning
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
General disorders
Multi-organ failure
|
0.13%
2/1553 • Number of events 2 • 18 months
|
|
General disorders
Pyrexia
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
General disorders
Sudden death
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.52%
8/1553 • Number of events 8 • 18 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.26%
4/1553 • Number of events 4 • 18 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Nervous system disorders
Dyskinesia
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
General disorders
Oedema peripheral
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.06%
1/1553 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
3/1553 • Number of events 3 • 18 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.06%
1/1553 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Pramipexole
n=1553 participants at risk
Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Psychiatric disorders
Hallucination
|
8.4%
131/1553 • Number of events 131 • 18 months
|
|
Nervous system disorders
Somnolence
|
9.5%
148/1553 • Number of events 148 • 18 months
|
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