Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00321854
First received: May 3, 2006
Last updated: May 7, 2014
Last verified: March 2014
Results First Received: December 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson Disease
Intervention: Drug: pramipexole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Participant Flow:   Overall Study
    Early Pramipexole     Delayed Pramipexole  
STARTED     261     274  
COMPLETED     198     192  
NOT COMPLETED     63     82  
Adverse Event                 41                 43  
Lack of Efficacy                 9                 14  
Protocol Violation                 6                 5  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 6                 17  
Unknown                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Total Total of all reporting groups

Baseline Measures
    Early Pramipexole     Delayed Pramipexole     Total  
Number of Participants  
[units: participants]
  261     274     535  
Age [1]
[units: Years]
Mean ± Standard Deviation
  62.1  ± 10.1     62.9  ± 9.9     62.5  ± 10  
Gender [1]
[units: participants]
     
Female     84     108     192  
Male     177     166     343  
[1] Treated set (TS)



  Outcome Measures
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1.  Primary:   Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

2.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

3.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

4.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

5.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

6.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

7.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15   [ Time Frame: Baseline and Month 15 ]

8.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9   [ Time Frame: Baseline and Month 9 ]

9.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6   [ Time Frame: Baseline and Month 6 ]

10.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3   [ Time Frame: Baseline and Month 3 ]

11.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

12.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15   [ Time Frame: Baseline and Month 15 ]

13.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9   [ Time Frame: Baseline and Month 9 ]

14.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6   [ Time Frame: Baseline and Month 6 ]

15.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3   [ Time Frame: Baseline and Month 3 ]

16.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

17.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15   [ Time Frame: Baseline and Month 15 ]

18.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9   [ Time Frame: Baseline and Month 9 ]

19.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6   [ Time Frame: Baseline and Month 6 ]

20.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3   [ Time Frame: Baseline and Month 3 ]

21.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

22.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

23.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

24.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

25.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

26.  Secondary:   Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15   [ Time Frame: Month 15 ]

27.  Secondary:   Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15   [ Time Frame: Baseline and Month 15 ]

28.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

29.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

30.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

31.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

32.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15   [ Time Frame: Baseline and Month 15 ]

33.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9   [ Time Frame: Baseline and Month 9 ]

34.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15   [ Time Frame: Baseline and Month 15 ]

35.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9   [ Time Frame: Baseline and Month 9 ]

36.  Secondary:   Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15   [ Time Frame: Baseline and Month 15 ]

37.  Secondary:   Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9   [ Time Frame: Baseline and Month 9 ]

38.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1   [ Time Frame: Month 1 ]

39.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6   [ Time Frame: Month 6 ]

40.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9   [ Time Frame: Month 9 ]

41.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12   [ Time Frame: Month 12 ]

42.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15   [ Time Frame: Month 15 ]

43.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1   [ Time Frame: Month 1 ]

44.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6   [ Time Frame: Month 6 ]

45.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9   [ Time Frame: Month 9 ]

46.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12   [ Time Frame: Month 12 ]

47.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15   [ Time Frame: Month 15 ]

48.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1   [ Time Frame: Month 1 ]

49.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6   [ Time Frame: Month 6 ]

50.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9   [ Time Frame: Month 9 ]

51.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12   [ Time Frame: Month 12 ]

52.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15   [ Time Frame: Month 15 ]

53.  Secondary:   Percentage Change From Baseline in the Striatum Uptake at Month 15   [ Time Frame: Baseline and Month 15 ]

54.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes   [ Time Frame: Baseline and Month 15 ]

55.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes   [ Time Frame: Baseline and Month 15 ]

56.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates   [ Time Frame: Baseline and Month 15 ]

57.  Secondary:   Clinically Significant Abnormalities in Vital Signs   [ Time Frame: Baseline and Month 15 ]


  Serious Adverse Events
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Time Frame Onset date after the date of first dose up to 48 hours after last dose of study drug.
Additional Description No text entered.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Serious Adverse Events
    Early Pramipexole     Delayed Pramipexole  
Total, serious adverse events      
# participants affected / at risk     25/261 (9.58%)     25/274 (9.12%)  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Angina pectoris † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Angina unstable † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Cardiac failure † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Cardiac failure congestive † 1    
# participants affected / at risk     1/261 (0.38%)     1/274 (0.36%)  
Coronary artery disease † 1    
# participants affected / at risk     1/261 (0.38%)     1/274 (0.36%)  
Mitral valve incompetence † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Palpitations † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Sinus bradycardia † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Ventricular tachycardia † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Congenital, familial and genetic disorders      
Hydrocele † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Ear and labyrinth disorders      
Deafness † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Eye disorders      
Macular hole † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Pterygium † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Gastrointestinal disorders      
Duodenal ulcer † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Inguinal hernia † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Small intestine obstruction † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Subileus † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
General disorders      
Chest pain † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Hyperplasia † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Pyrexia † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Infections and infestations      
Urinary tract infection † 1    
# participants affected / at risk     0/261 (0.00%)     2/274 (0.73%)  
Bacterial infection † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Gastroenteristis † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Influenza † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Localised infection † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Respiratory tract infection † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Sepsis † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Staphylococcal infection † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Subcutaneous abscess † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Injury, poisoning and procedural complications      
Facial bones fracture † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Fall † 1    
# participants affected / at risk     1/261 (0.38%)     1/274 (0.36%)  
Radial nerve injury † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Subdural haematoma † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Hypoglycaemia † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Musculoskeletal and connective tissue disorders      
Foot deformity † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Musculoskeletal chest pain † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Osteoarthritis † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Rhabdomyolysis † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Breast cancer † 1    
# participants affected / at risk     0/261 (0.00%)     2/274 (0.73%)  
Large cell carcinoma of the respiratory tract stage unspecified † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Lung neoplasm malignant † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Mesothelioma † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Multiple myeloma † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Ovarian neoplasm † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Nervous system disorders      
Transient ischaemic attack † 1    
# participants affected / at risk     2/261 (0.77%)     1/274 (0.36%)  
Epilepsy † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Loss of consciousness † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Pakinson's disease † 1    
# participants affected / at risk     1/261 (0.38%)     1/274 (0.36%)  
Pakinsonism † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Peroneal nerve palsy † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Presyncope † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Sciatica † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Syncope † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Psychiatric disorders      
Hallucination † 1    
# participants affected / at risk     2/261 (0.77%)     0/274 (0.00%)  
Anxiety † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Completed suicide † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Confusional state † 1    
# participants affected / at risk     1/261 (0.38%)     1/274 (0.36%)  
Renal and urinary disorders      
Dysuria † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Renal failure acute † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Reproductive system and breast disorders      
Breast disorder † 1    
# participants affected / at risk     1/261 (0.38%)     0/274 (0.00%)  
Varicocele † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Vascular disorders      
Orthostatic hypotension † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Peripheral arterial occulsive disease † 1    
# participants affected / at risk     0/261 (0.00%)     1/274 (0.36%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00321854     History of Changes
Other Study ID Numbers: 248.595
Study First Received: May 3, 2006
Results First Received: December 18, 2009
Last Updated: May 7, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna, Austria
Finland: Finnish Medicines Agency
France: AFFSAPS
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Comitato Etico dell'Az. USL 12 di Viareggio - VIAREGGIO
Japan: Ministry of Health, Labor and Welfare
Spain: Spanish Agency for Medicines and Health Products
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden
United States: Food and Drug Administration