Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00479401
First received: May 25, 2007
Last updated: June 20, 2014
Last verified: June 2014
Results First Received: November 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Early Parkinson Disease (Early PD)
Interventions: Drug: Pramipexol Extended Release
Drug: Pramipexol Immediate Release
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
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

Participant Flow:   Overall Study
    Pramipexole Extended Release (PPX ER)     Pramipexole Immediate Release (PPX IR)     Placebo  
STARTED     223     213     103  
COMPLETED     174     176     91  
NOT COMPLETED     49     37     12  
Adverse Event                 24                 20                 4  
Lack of Efficacy                 2                 2                 4  
Protocol Violation                 2                 1                 1  
Lost to Follow-up                 1                 1                 1  
Withdrawal by Subject                 16                 10                 2  
Exclusion criteria, relocation                 4                 3                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
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
Total Total of all reporting groups

Baseline Measures
    Pramipexole Extended Release (PPX ER)     Pramipexole Immediate Release (PPX IR)     Placebo     Total  
Number of Participants  
[units: participants]
  223     213     103     539  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 9.8     61.7  ± 9.6     62.0  ± 9.6     61.6  ± 9.7  
Gender  
[units: participants]
       
Female     96     92     52     240  
Male     127     121     51     299  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score   [ Time Frame: baseline and after 33 weeks treatment ]

2.  Secondary:   Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale   [ Time Frame: after 18 weeks of treatment compared to baseline ]

3.  Secondary:   Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale   [ Time Frame: after 18 weeks of treatment compared to baseline ]

4.  Secondary:   UPDRS II+III Responder Rate (at Least 20% Improvement)   [ Time Frame: after 33 weeks treatment ]

5.  Secondary:   UPDRS Part I Change From Baseline   [ Time Frame: baseline and after 33 weeks treatment ]

6.  Secondary:   UPDRS Part II Total Score   [ Time Frame: after 33 weeks treatment ]

7.  Secondary:   UPDRS Part III Total Score   [ Time Frame: after 33 weeks treatment ]

8.  Secondary:   Beck's Depression Inventory Version I A   [ Time Frame: after 33 weeks treatment ]

9.  Secondary:   Likert Scale for Pain Related to PD   [ Time Frame: after 33 weeks treatment ]

10.  Secondary:   Parkinson's Disease Sleep Scale (PDSS)   [ Time Frame: after 33 weeks treatment ]

11.  Secondary:   Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score   [ Time Frame: after 33 weeks treatment ]

12.  Secondary:   Change From Baseline in European Quality of Life Visual Analog Scale   [ Time Frame: after 33 weeks treatment ]

13.  Secondary:   Patients Who Started to Use L-Dopa Rescue Medication   [ Time Frame: from trial start on to any time before final assessment of the patient, up to 33 weeks ]

14.  Secondary:   Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)   [ Time Frame: from trial start on to any time before final assessment of the patient, up to 33 weeks ]

15.  Secondary:   Possible Clinically Significant Abnormal Laboratory Parameters   [ Time Frame: baseline and after 33 weeks of treatment ]

16.  Secondary:   Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events   [ Time Frame: baseline and after 33 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00479401     History of Changes
Other Study ID Numbers: 248.524, Eudract No 2007-000073-39
Study First Received: May 25, 2007
Results First Received: November 20, 2009
Last Updated: June 20, 2014
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Austria: Federal Office for Safety in Health Care
Czech Republic: SUKL (state institute for drug control)
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health, Malaysia
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control)
Taiwan: Department of Health, Executive Yuan, Taiwan
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration