Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558025
First received: November 12, 2007
Last updated: December 22, 2013
Last verified: May 2012
Results First Received: May 26, 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
Interventions: Drug: Pramipexole Extended Release
Drug: Pramipexole Immediate Release

  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
Pramipexole Extended Release (ER) 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
Pramipexole Immediate Release (IR) 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os

Participant Flow:   Overall Study
    Pramipexole Extended Release (ER)     Pramipexole Immediate Release (IR)  
STARTED     104     52  
COMPLETED     100     49  
NOT COMPLETED     4     3  
Adverse Event                 1                 1  
Withdrawal by Subject                 2                 2  
Protocol Violation                 1                 0  



  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
Pramipexole Extended Release (ER) 0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
Pramipexole Immediate Release (IR) 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
Total Total of all reporting groups

Baseline Measures
    Pramipexole Extended Release (ER)     Pramipexole Immediate Release (IR)     Total  
Number of Participants  
[units: participants]
  104     52     156  
Age  
[units: Years]
Mean ± Standard Deviation
  63.8  ± 8.8     63.5  ± 9.7     63.7  ± 9.1  
Gender  
[units: participants]
     
Female     47     21     68  
Male     57     31     88  



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)   [ Time Frame: from baseline to week 9 ]

2.  Secondary:   Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)   [ Time Frame: from baseline to week 4 ]

3.  Secondary:   Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)   [ Time Frame: Baseline and week 9 ]

4.  Secondary:   Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)   [ Time Frame: Baseline and week 9 ]

5.  Secondary:   Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)   [ Time Frame: Baseline and week 9 ]

6.  Secondary:   Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)   [ Time Frame: Week 9 ]

7.  Secondary:   Patient Global Impression - Improvement (PGI-I), FAS (LOCF)   [ Time Frame: Week 9 ]

8.  Secondary:   Pramipexole Dose Adaptation, FAS (LOCF)   [ Time Frame: Week 9 ]

9.  Secondary:   Final Pramipexole Dose (mg) After 9 Weeks, Treated Set   [ Time Frame: Week 9 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
There were no serious adverse events in the trial and no non-serious adverse events with an incidence >5%.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Pharmaceuticals
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: NCT00558025     History of Changes
Other Study ID Numbers: 248.636, Eudract 2007-003353-90
Study First Received: November 12, 2007
Results First Received: May 26, 2009
Last Updated: December 22, 2013
Health Authority: France: AFSSAPS 143/147, bld Anatole France 93285 Saint-Denis Cedex FRANCE
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)