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Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

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ClinicalTrials.gov Identifier: NCT00615914
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : November 23, 2010
Last Update Posted : July 11, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson Disease
Enrollment 1645

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pramipexole
Hide Arm/Group Description Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
Period Title: Overall Study
Started 1645 [1]
Completed 1008
Not Completed 637
Reason Not Completed
Adverse Event             274
Death             20
Lack of Efficacy             59
Lost to Follow-up             187
Withdrawal by Subject             16
Physician Decision             4
No data was collected.             65
No treatment             2
Irregularly enrolled patients             10
[1]
The number of patients enrolled
Arm/Group Title Pramipexole
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 1553
Hide Baseline Analysis Population Description
Data set for safety analysis - The number of patients enrolled was 1645. The number of case report forms which were collected was 1581. Moreover the number of patients analyzed as safety analysis was 1553 because 28 patients were excluded due to protocol violations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1553 participants
69.0  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1553 participants
Female
890
  57.3%
Male
663
  42.7%
1.Primary Outcome
Title Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Hide Description 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.
Time Frame during 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pramipexole
Hide Arm/Group Description:
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 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).
Overall Number of Participants Analyzed 1553
Measure Type: Number
Unit of Measure: percentage of participants
Proportion of Adverse Events 42.4
Proportion of Adverse Drug Reactions 34.5
Proportion of Serious Adverse Events 7.2
2.Secondary Outcome
Title Clinical Global Impression of Improvement
Hide Description Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pramipexole
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 1527
Measure Type: Number
Unit of Measure: Participants
Very much improved 48
Much improved 561
Minimally improved 484
No effect 209
Unassessable 225
3.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Hide Description 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.
Time Frame Baseline and at 18 months (or at the time of discontinuation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Pramipexole
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 1356
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
-5.4  (10.7)
4.Secondary Outcome
Title Change From Baseline in Modified Hoehn & Yahr Rating Scale
Hide Description 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).
Time Frame Baseline and at 18 months (or at the time of discontinuation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Pramipexole
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 1430
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
-0.2  (0.6)
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pramipexole
Hide Arm/Group Description 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).
All-Cause Mortality
Pramipexole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pramipexole
Affected / at Risk (%) # Events
Total   111/1553 (7.15%)    
Cardiac disorders   
Acute myocardial infarction  1  1/1553 (0.06%)  1
Angina pectoris  1  1/1553 (0.06%)  1
Cardiac failure  1  3/1553 (0.19%)  3
Cardiac failure acute  1  1/1553 (0.06%)  1
Cardio-respiratory arrest  1  1/1553 (0.06%)  1
Myocardial infarction  1  1/1553 (0.06%)  1
Sick sinus syndrome  1  1/1553 (0.06%)  1
Tricuspid valve incompetence  1  1/1553 (0.06%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/1553 (0.06%)  1
Constipation  1  2/1553 (0.13%)  2
Diarrhoea  1  1/1553 (0.06%)  1
Dyspepsia  1  1/1553 (0.06%)  1
Gastrointestinal haemorrhage  1  1/1553 (0.06%)  1
Haematemesis  1  1/1553 (0.06%)  1
Ileus paralytic  1  1/1553 (0.06%)  1
Nausea  1  1/1553 (0.06%)  1
Volvulus  1  1/1553 (0.06%)  1
Vomiting  1  1/1553 (0.06%)  1
General disorders   
Chest pain  1  1/1553 (0.06%)  1
Death  1  2/1553 (0.13%)  2
Drowning  1  2/1553 (0.13%)  2
Multi-organ failure  1  2/1553 (0.13%)  2
Pyrexia  1  1/1553 (0.06%)  1
Sudden death  1  1/1553 (0.06%)  1
Oedema peripheral  1  1/1553 (0.06%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/1553 (0.06%)  1
Cholelithiasis  1  1/1553 (0.06%)  1
Liver disorder  1  1/1553 (0.06%)  1
Infections and infestations   
Influenza  1  1/1553 (0.06%)  1
Pneumonia  1  16/1553 (1.03%)  16
Pneumonia staphylococcal  1  1/1553 (0.06%)  1
Pyothorax  1  1/1553 (0.06%)  1
Injury, poisoning and procedural complications   
Fall  1  8/1553 (0.52%)  8
Femoral neck fracture  1  3/1553 (0.19%)  3
Femur fracture  1  3/1553 (0.19%)  3
Heat stroke  1  1/1553 (0.06%)  1
Joint dislocation  1  1/1553 (0.06%)  1
Patella fracture  1  1/1553 (0.06%)  1
Spinal compression fracture  1  4/1553 (0.26%)  4
Tendon rupture  1  1/1553 (0.06%)  1
Cervical vertebral fracture  1  1/1553 (0.06%)  1
Lumbar vertebral fracture  1  1/1553 (0.06%)  1
Pelvic fracture  1  1/1553 (0.06%)  1
Ligament rupture  1  1/1553 (0.06%)  1
Brain herniation  1  1/1553 (0.06%)  1
Road traffic accident  1  3/1553 (0.19%)  3
Contusion  1  1/1553 (0.06%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/1553 (0.06%)  1
Hyperglycaemia  1  1/1553 (0.06%)  1
Decreased appetite  1  2/1553 (0.13%)  2
Musculoskeletal and connective tissue disorders   
Posture abnormal  1  1/1553 (0.06%)  1
Scoliosis  1  1/1553 (0.06%)  1
Spinal osteoarthritis  1  1/1553 (0.06%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/1553 (0.06%)  1
Gastric cancer  1  1/1553 (0.06%)  1
Ovarian cancer  1  1/1553 (0.06%)  1
Large intestine carcinoma  1  1/1553 (0.06%)  1
Gastric neoplasm  1  1/1553 (0.06%)  1
Ureteric cancer  1  1/1553 (0.06%)  1
Nervous system disorders   
Brain stem infarction  1  1/1553 (0.06%)  1
Cerebral haemorrhage  1  2/1553 (0.13%)  2
Cerebral infarction  1  2/1553 (0.13%)  2
Coma hepatic  1  1/1553 (0.06%)  1
Convulsion  1  2/1553 (0.13%)  2
Dizziness  1  2/1553 (0.13%)  2
Headache  1  1/1553 (0.06%)  1
Neuroleptic malignant syndrome  1  2/1553 (0.13%)  2
Somnolence  1  3/1553 (0.19%)  3
Subarachnoid haemorrhage  1  1/1553 (0.06%)  1
Sudden onset of sleep  1  3/1553 (0.19%)  3
Cerebral haematoma  1  1/1553 (0.06%)  1
Putamen haemorrhage  1  1/1553 (0.06%)  1
Cerebrovascular accident  1  1/1553 (0.06%)  1
Dyskinesia  1  3/1553 (0.19%)  3
Psychiatric disorders   
Agitation  1  2/1553 (0.13%)  2
Confusional state  1  3/1553 (0.19%)  3
Delirium  1  7/1553 (0.45%)  7
Delusion  1  6/1553 (0.39%)  6
Hallucination  1  7/1553 (0.45%)  7
Hallucination, auditory  1  1/1553 (0.06%)  1
Persecutory delusion  1  1/1553 (0.06%)  1
Suicide attempt  1  1/1553 (0.06%)  1
Bipolar disorder  1  1/1553 (0.06%)  1
Renal and urinary disorders   
Renal failure acute  1  1/1553 (0.06%)  1
Crush syndrome  1  1/1553 (0.06%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/1553 (0.06%)  1
Asphyxia  1  4/1553 (0.26%)  4
Pleural haemorrhage  1  1/1553 (0.06%)  1
Pneumonia aspiration  1  5/1553 (0.32%)  5
Pulmonary embolism  1  1/1553 (0.06%)  1
Pulmonary oedema  1  1/1553 (0.06%)  1
Respiratory failure  1  3/1553 (0.19%)  3
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  3/1553 (0.19%)  3
Skin ulcer  1  1/1553 (0.06%)  1
Vascular disorders   
Shock  1  2/1553 (0.13%)  2
Deep vein thrombosis  1  1/1553 (0.06%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pramipexole
Affected / at Risk (%) # Events
Total   267/1553 (17.19%)    
Nervous system disorders   
Somnolence  1  148/1553 (9.53%)  148
Psychiatric disorders   
Hallucination  1  131/1553 (8.44%)  131
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615914     History of Changes
Other Study ID Numbers: 248.547
First Submitted: January 31, 2008
First Posted: February 14, 2008
Results First Submitted: September 8, 2010
Results First Posted: November 23, 2010
Last Update Posted: July 11, 2014