Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00297778
First received: February 28, 2006
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: May 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Parkinson Disease
Depression
Interventions: Drug: Pramipexole
Other: 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
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Participant Flow:   Overall Study
    Placebo     Pramipexole  
STARTED     152     144  
COMPLETED     133     124  
NOT COMPLETED     19     20  
Adverse Event                 16                 10  
Withdrawal by Subject                 1                 5  
Lack of Efficacy                 2                 1  
Non-compliant with trial protocol                 0                 3  
Other                 0                 1  



  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
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
Total Total of all reporting groups

Baseline Measures
    Placebo     Pramipexole     Total  
Number of Participants  
[units: participants]
  152     144     296  
Age  
[units: Years]
Mean ± Standard Deviation
  66.6  ± 9.9     67.4  ± 9.0     67  ± 9.5  
Gender  
[units: participants]
     
Female     74     82     156  
Male     78     62     140  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Change From Baseline in the UPDRS Part II Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline in the UPDRS Part III Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Change From Baseline in the UPDRS Part II+III Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Clinical Global Impressions of Global Improvement (CGI-I) at Week 12   [ Time Frame: Week 12 ]

10.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:   Change From Baseline in the UPDRS Part I Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

14.  Secondary:   Change From Baseline in the UPDRS Part IV Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

15.  Secondary:   Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame First drug intake up to 48 hours after the last drug intake
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo Placebo tablet matching active treatment
Pramipexole Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.

Other Adverse Events
    Placebo     Pramipexole  
Total, other (not including serious) adverse events      
# participants affected     58     71  
Ear and labyrinth disorders      
Vertigo † 1    
# participants affected / at risk     4/152 (2.63%)     10/144 (6.94%)  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     26/152 (17.11%)     24/144 (16.67%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     9/152 (5.92%)     8/144 (5.56%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     9/152 (5.92%)     16/144 (11.11%)  
Headache † 1    
# participants affected / at risk     12/152 (7.89%)     16/144 (11.11%)  
Somnolence † 1    
# participants affected / at risk     12/152 (7.89%)     15/144 (10.42%)  
Dyskinesia † 1    
# participants affected / at risk     4/152 (2.63%)     10/144 (6.94%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     4/152 (2.63%)     8/144 (5.56%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0



  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.


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.  


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 by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00297778     History of Changes
Other Study ID Numbers: 248.596, Eudract 2005-003788-22
Study First Received: February 28, 2006
Results First Received: May 22, 2009
Last Updated: March 6, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Finland: Finnish Medicines Agency
France: Afssaps
Germany: Ethikkommission bei der Landesaerztekammer Baden-Wuerttemberg
Italy: Comitato Etico Ospedale Civile S. Spirito, Università "G. D'Annunzio"
Netherlands: Medish Etische toetsingscommissie Atrium MC
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
South Africa: Medicines Council Country
Spain: Unidad de Registro y Tasas, Agencia Espanola del medicamento y productos sanitarios
Sweden: Medical Products Agency
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)