Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00613301
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : November 23, 2010
Last Update Posted : June 6, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson Disease
Enrollment 416
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pramipexole
Hide Arm/Group Description BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
Period Title: Overall Study
Started 416
Completed 188
Not Completed 228
Reason Not Completed
Adverse Event             49
Lost to Follow-up             88
Withdrawal by Subject             5
Death             6
Lack of Efficacy             13
Physician Decision             2
No data was collected             53
Irregularly enrolled patients             12
Arm/Group Title Pramipexole
Hide Arm/Group Description The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
Overall Number of Baseline Participants 346
Hide Baseline Analysis Population Description
Data Set for Safety Analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 346 participants
66.2  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 346 participants
Female
187
  54.0%
Male
159
  46.0%
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 safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
Time Frame during 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.
Arm/Group Title Pramipexole
Hide Arm/Group Description:
Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
Overall Number of Participants Analyzed 346
Measure Type: Number
Unit of Measure: Proportion (percentage of participants)
Proportion of Adverse Events 51.7
Proportion of Adverse Drug Reactions 41.3
Proportion of Serious Adverse Events 8.4
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 after 36 months treatment
Hide Outcome Measure Data
Hide Analysis Population Description
There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn’t suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.
Arm/Group Title Pramipexole
Hide Arm/Group Description:
BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
Overall Number of Participants Analyzed 339
Measure Type: Number
Unit of Measure: Participants
Very much improved 19
Much improved 137
Minimally improved 97
No effect 15
Unassessable 71
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 36 months (or at the time of discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.
Arm/Group Title Pramipexole
Hide Arm/Group Description:
BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
Overall Number of Participants Analyzed 291
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
-5.2  (11.2)
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 36 months (or at the time of discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients (295) means a population who have the assessment of Modified Hoehn & Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.
Arm/Group Title Pramipexole
Hide Arm/Group Description:
BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
Overall Number of Participants Analyzed 295
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
-0.1  (0.7)
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
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).
All-Cause Mortality
Pramipexole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pramipexole
Affected / at Risk (%)
Total   29/346 (8.38%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia  1  1/346 (0.29%) 
Cardiac disorders   
Angina pectoris  1  1/346 (0.29%) 
Myocardial infarction  1  1/346 (0.29%) 
Gastrointestinal disorders   
Ileus  1  1/346 (0.29%) 
Inguinal hernia  1  1/346 (0.29%) 
General disorders   
Death  1  1/346 (0.29%) 
Hernia  1  1/346 (0.29%) 
Pyrexia  1  1/346 (0.29%) 
Hepatobiliary disorders   
Jaundice  1  1/346 (0.29%) 
Infections and infestations   
Pneumonia  1  1/346 (0.29%) 
Septic shock  1  1/346 (0.29%) 
Injury, poisoning and procedural complications   
Compression fracture  1  1/346 (0.29%) 
Foot fracture  1  1/346 (0.29%) 
Spinal compression fracture  1  1/346 (0.29%) 
Investigations   
C-reactive protein increased  1  1/346 (0.29%) 
Platelet count decreased  1  1/346 (0.29%) 
White blood cell count increased  1  1/346 (0.29%) 
Metabolism and nutrition disorders   
Cachexia  1  1/346 (0.29%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/346 (0.29%) 
Rhabdomyolysis  1  1/346 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/346 (0.29%) 
Metastases to lung  1  1/346 (0.29%) 
Lung neoplasm malignant  1  2/346 (0.58%) 
Large intestine carcinoma  1  1/346 (0.29%) 
Nervous system disorders   
Cerebral haemorrhage  1  1/346 (0.29%) 
Cerebral infarction  1  3/346 (0.87%) 
Diabetic hyperosmolar coma  1  1/346 (0.29%) 
Neuroleptic malignant syndrome  1  2/346 (0.58%) 
Thalamus haemorrhage  1  1/346 (0.29%) 
Psychiatric disorders   
Agitation  1  1/346 (0.29%) 
Delusion  1  1/346 (0.29%) 
Hallucination  1  1/346 (0.29%) 
Renal and urinary disorders   
Neurogenic bladder  1  1/346 (0.29%) 
Urinary retention  1  1/346 (0.29%) 
Renal impairment  1  1/346 (0.29%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/346 (0.29%) 
Haemoptysis  1  1/346 (0.29%) 
Pneumonia aspiration  1  3/346 (0.87%) 
Stridor  1  1/346 (0.29%) 
Skin and subcutaneous tissue disorders   
Eczema  1  1/346 (0.29%) 
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 (%)
Total   106/346 (30.64%) 
Gastrointestinal disorders   
Constipation  1  25/346 (7.23%) 
Nausea  1  20/346 (5.78%) 
Nervous system disorders   
Somnolence  1  59/346 (17.05%) 
Psychiatric disorders   
Hallucination  1  28/346 (8.09%) 
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00613301     History of Changes
Other Study ID Numbers: 248.549
First Submitted: January 31, 2008
First Posted: February 13, 2008
Results First Submitted: September 8, 2010
Results First Posted: November 23, 2010
Last Update Posted: June 6, 2014