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

Primary Purpose

Parkinson Disease, Depression

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pramipexole
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 15-item Geriatric Depression Scale (GDS) > or = 5 Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2 Folsteins Mini-Mental State Examination (MMSE) score > 24 Male or female patient with PD (UK PD Brain Bank criteria). Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms . Male or female patients aged 30 - 80 years. Ability to provide written informed consent. Women of childbearing potential must have a negative serum beta-humanchoriongonadotropin (Beta-HCG) pregnancy test at the Screening visit unless surgically sterile or last menstruation >or = 12 months prior to signing informed consent. Women of childbearing potential must be using an accepted contraceptive. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients. History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential. Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases. History of PD stereotactic brain surgery. Surgery within 180 days of randomization that would negatively impact the patients participation in the study. History of active epilepsy within the past year. Current psychotherapy or behavior therapy while participating the trial Symptomatic orthostatic hypotension prior to randomization. Malignant melanoma or history of previously treated malignant melanoma. Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months. Patients who have received dopamine agonists within the past 30 days Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1). Patients who are currently lactating. Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization. Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient Any other clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient

Sites / Locations

  • 248.596.43003 Boehringer Ingelheim Investigational Site
  • 248.596.43001 Boehringer Ingelheim Investigational Site
  • 248.596.43005 Boehringer Ingelheim Investigational Site
  • 248.596.43004 Boehringer Ingelheim Investigational Site
  • 248.596.43002 Boehringer Ingelheim Investigational Site
  • 248.596.35801 Boehringer Ingelheim Investigational Site
  • 248.596.3302B Centre Hospitalier du Pays d'Aix
  • 248.596.3302A Centre Hospitalier du Pays d'Aix
  • 248.596.3306A Hôpital Pierre Wertheimer
  • 248.596.3308A Hôpital Gabriel Montpied
  • 248.596.3309A Cabinet Médical
  • 248.596.3307A Hôpital Roger Salengro
  • 248.596.3307B Hôpital Roger Salengro
  • 248.596.3307C Hôpital Roger Salengro
  • 248.596.3303A Hôpital La Timone
  • 248.596.3305A Hôpital du Haut Levêque
  • 248.596.3305B Hôpital du Haut Levêque
  • 248.596.3301A Hôpital Guillaume et René Laennec
  • 248.596.49012 Boehringer Ingelheim Investigational Site
  • 248.596.49002 Boehringer Ingelheim Investigational Site
  • 248.596.49013 Boehringer Ingelheim Investigational Site
  • 248.596.49015 Boehringer Ingelheim Investigational Site
  • 248.596.49003 Boehringer Ingelheim Investigational Site
  • 248.596.49004 Boehringer Ingelheim Investigational Site
  • 248.596.49001 Boehringer Ingelheim Investigational Site
  • 248.596.49016 Boehringer Ingelheim Investigational Site
  • 248.596.49005 Boehringer Ingelheim Investigational Site
  • 248.596.49014 Boehringer Ingelheim Investigational Site
  • 248.596.49008 Boehringer Ingelheim Investigational Site
  • 248.596.39008 Clinica Neurologica I Policlinico di Catania
  • 248.596.39004 Neurologia Ospedale della Misericordia
  • 248.596.39005 Clinica Neurologica Policlinico G. Martino
  • 248.596.39009 Istituti Clinici di Perfezionamento
  • 248.596.39003 Università degli studi di Napoli "Federico II"
  • 248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"
  • 248.596.39007 Clinica Neurologica Policlinico Tor Vergata
  • 248.596.39006 Neurologia Ospedale Evangelico Valdese
  • 248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA
  • 248.596.31007 Afdeling neurologie
  • 248.596.31005 Ziekenhuis Gooi-Noord
  • 248.596.31004 Amphia ziekenhuis, Locatie Molengracht
  • 248.596.31002 Canisius-Wilhelmina Ziekenhuis
  • 248.596.31001 Maasland Ziekenhuis
  • 248.596.47002 Boehringer Ingelheim Investigational Site
  • 248.596.47004 Boehringer Ingelheim Investigational Site
  • 248.596.47003 Boehringer Ingelheim Investigational Site
  • 248.596.40003 Boehringer Ingelheim Investigational Site
  • 248.596.40004 Boehringer Ingelheim Investigational Site
  • 248.596.40005 Boehringer Ingelheim Investigational Site
  • 248.596.40001 Boehringer Ingelheim Investigational Site
  • 248.596.40002 Boehringer Ingelheim Investigational Site
  • 248.596.40006 Country Clinical Emergency Hospital
  • 248.596.70001 Boehringer Ingelheim Investigational Site
  • 248.596.70003 Boehringer Ingelheim Investigational Site
  • 248.596.70002 Boehringer Ingelheim Investigational Site
  • 248.596.70004 Boehringer Ingelheim Investigational Site
  • 248.596.70005 Boehringer Ingelheim Investigational Site
  • 248.596.27001 Boehringer Ingelheim Investigational Site
  • 248.596.27003 Boehringer Ingelheim Investigational Site
  • 248.596.27007 Boehringer Ingelheim Investigational Site
  • 248.596.27008 Boehringer Ingelheim Investigational Site
  • 248.596.27004 Boehringer Ingelheim Investigational Site
  • 248.596.27006 Boehringer Ingelheim Investigational Site
  • 248.596.34003 Hospital de Alcorcón. Departamento de Neurología
  • 248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología
  • 248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología
  • 248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología
  • 248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología
  • 248.596.34004 Hospital General de Catalunya. Departamento de Neurología
  • 248.596.46004 Boehringer Ingelheim Investigational Site
  • 248.596.46001 Boehringer Ingelheim Investigational Site
  • 248.596.46002 Boehringer Ingelheim Investigational Site
  • 248.596.38004 Boehringer Ingelheim Investigational Site
  • 248.596.38005 Boehringer Ingelheim Investigational Site
  • 248.596.38002 Boehringer Ingelheim Investigational Site
  • 248.596.38006 Boehringer Ingelheim Investigational Site
  • 248.596.38003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pramipexole

placebo

Arm Description

A daily dose of pramipexole 0.125 mg t.i.d.; titration-to-response up to 1.0 mg t.i.d.

Placebo (matching) tablets

Outcomes

Primary Outcome Measures

Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

Secondary Outcome Measures

Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
BDI clinical response was defined as a reduction of ≥50% from baseline
Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
Change From Baseline in the UPDRS Part II Total Score at Week 12
Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
Change From Baseline in the UPDRS Part III Total Score at Week 12
The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)
Change From Baseline in the UPDRS Part II+III Total Score at Week 12
The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).
Change From Baseline in the UPDRS Part I Total Score at Week 12
The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.
Change From Baseline in the UPDRS Part IV Total Score at Week 12
The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs

Full Information

First Posted
February 28, 2006
Last Updated
June 3, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00297778
Brief Title
Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance. However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression. The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients. Also data on the safety of the product in the disease will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pramipexole
Arm Type
Experimental
Arm Description
A daily dose of pramipexole 0.125 mg t.i.d.; titration-to-response up to 1.0 mg t.i.d.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (matching) tablets
Intervention Type
Drug
Intervention Name(s)
Pramipexole
Intervention Description
Dopamine agonist
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
Description
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
Description
BDI clinical response was defined as a reduction of ≥50% from baseline
Time Frame
Week 12
Title
Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
Description
The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
Time Frame
Baseline and Week 12
Title
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
Description
The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
Time Frame
Baseline and Week 12
Title
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
Description
The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
Time Frame
Baseline and Week 12
Title
Change From Baseline in the UPDRS Part II Total Score at Week 12
Description
Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
Time Frame
Baseline and Week 12
Title
Change From Baseline in the UPDRS Part III Total Score at Week 12
Description
The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)
Time Frame
Baseline and Week 12
Title
Change From Baseline in the UPDRS Part II+III Total Score at Week 12
Description
The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)
Time Frame
Baseline and Week 12
Title
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
Description
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)
Time Frame
Week 12
Title
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
Description
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Time Frame
Baseline and Week 12
Title
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
Description
This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
Description
The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).
Time Frame
Baseline and Week 12
Title
Change From Baseline in the UPDRS Part I Total Score at Week 12
Description
The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.
Time Frame
Baseline and Week 12
Title
Change From Baseline in the UPDRS Part IV Total Score at Week 12
Description
The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.
Time Frame
Baseline and Week 12
Title
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 15-item Geriatric Depression Scale (GDS) > or = 5 Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2 Folsteins Mini-Mental State Examination (MMSE) score > 24 Male or female patient with PD (UK PD Brain Bank criteria). Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms . Male or female patients aged 30 - 80 years. Ability to provide written informed consent. Women of childbearing potential must have a negative serum beta-humanchoriongonadotropin (Beta-HCG) pregnancy test at the Screening visit unless surgically sterile or last menstruation >or = 12 months prior to signing informed consent. Women of childbearing potential must be using an accepted contraceptive. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients. History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential. Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases. History of PD stereotactic brain surgery. Surgery within 180 days of randomization that would negatively impact the patients participation in the study. History of active epilepsy within the past year. Current psychotherapy or behavior therapy while participating the trial Symptomatic orthostatic hypotension prior to randomization. Malignant melanoma or history of previously treated malignant melanoma. Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months. Patients who have received dopamine agonists within the past 30 days Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1). Patients who are currently lactating. Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization. Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient Any other clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
248.596.43003 Boehringer Ingelheim Investigational Site
City
Graz
Country
Austria
Facility Name
248.596.43001 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
248.596.43005 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
248.596.43004 Boehringer Ingelheim Investigational Site
City
St. Pölten
Country
Austria
Facility Name
248.596.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
248.596.35801 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
248.596.3302B Centre Hospitalier du Pays d'Aix
City
Aix en Provence cedex 1
Country
France
Facility Name
248.596.3302A Centre Hospitalier du Pays d'Aix
City
Aix en Provence
Country
France
Facility Name
248.596.3306A Hôpital Pierre Wertheimer
City
Bron cedex
Country
France
Facility Name
248.596.3308A Hôpital Gabriel Montpied
City
Clermont Ferrand
Country
France
Facility Name
248.596.3309A Cabinet Médical
City
Evreux
Country
France
Facility Name
248.596.3307A Hôpital Roger Salengro
City
Lille cedex
Country
France
Facility Name
248.596.3307B Hôpital Roger Salengro
City
Lille cedex
Country
France
Facility Name
248.596.3307C Hôpital Roger Salengro
City
Lille cedex
Country
France
Facility Name
248.596.3303A Hôpital La Timone
City
Marseille cedex 5
Country
France
Facility Name
248.596.3305A Hôpital du Haut Levêque
City
Pessac cédex
Country
France
Facility Name
248.596.3305B Hôpital du Haut Levêque
City
Pessac cédex
Country
France
Facility Name
248.596.3301A Hôpital Guillaume et René Laennec
City
Saint Herblain
Country
France
Facility Name
248.596.49012 Boehringer Ingelheim Investigational Site
City
Berlin-Steglitz
Country
Germany
Facility Name
248.596.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.596.49013 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.596.49015 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.596.49003 Boehringer Ingelheim Investigational Site
City
Bremerhaven
Country
Germany
Facility Name
248.596.49004 Boehringer Ingelheim Investigational Site
City
Gera
Country
Germany
Facility Name
248.596.49001 Boehringer Ingelheim Investigational Site
City
Karlsruhe
Country
Germany
Facility Name
248.596.49016 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
248.596.49005 Boehringer Ingelheim Investigational Site
City
Marburg
Country
Germany
Facility Name
248.596.49014 Boehringer Ingelheim Investigational Site
City
Mittweida
Country
Germany
Facility Name
248.596.49008 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
248.596.39008 Clinica Neurologica I Policlinico di Catania
City
Catania
Country
Italy
Facility Name
248.596.39004 Neurologia Ospedale della Misericordia
City
Grosseto
Country
Italy
Facility Name
248.596.39005 Clinica Neurologica Policlinico G. Martino
City
Messina
Country
Italy
Facility Name
248.596.39009 Istituti Clinici di Perfezionamento
City
Milano
Country
Italy
Facility Name
248.596.39003 Università degli studi di Napoli "Federico II"
City
Napoli
Country
Italy
Facility Name
248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"
City
Pescara
Country
Italy
Facility Name
248.596.39007 Clinica Neurologica Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
248.596.39006 Neurologia Ospedale Evangelico Valdese
City
Torino
Country
Italy
Facility Name
248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA
City
's-Hertogenbosch
Country
Netherlands
Facility Name
248.596.31007 Afdeling neurologie
City
Amsterdam
Country
Netherlands
Facility Name
248.596.31005 Ziekenhuis Gooi-Noord
City
Blaricum
Country
Netherlands
Facility Name
248.596.31004 Amphia ziekenhuis, Locatie Molengracht
City
Breda
Country
Netherlands
Facility Name
248.596.31002 Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
248.596.31001 Maasland Ziekenhuis
City
Sittard
Country
Netherlands
Facility Name
248.596.47002 Boehringer Ingelheim Investigational Site
City
Arendal
Country
Norway
Facility Name
248.596.47004 Boehringer Ingelheim Investigational Site
City
Lillehammer
Country
Norway
Facility Name
248.596.47003 Boehringer Ingelheim Investigational Site
City
Sandvika
Country
Norway
Facility Name
248.596.40003 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
248.596.40004 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
248.596.40005 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
248.596.40001 Boehringer Ingelheim Investigational Site
City
Cluj Napoca
Country
Romania
Facility Name
248.596.40002 Boehringer Ingelheim Investigational Site
City
Iasi
Country
Romania
Facility Name
248.596.40006 Country Clinical Emergency Hospital
City
Targu-Mures
Country
Romania
Facility Name
248.596.70001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.596.70003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.596.70002 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
248.596.70004 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
248.596.70005 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
248.596.27001 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
248.596.27003 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
248.596.27007 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
248.596.27008 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
248.596.27004 Boehringer Ingelheim Investigational Site
City
Pretoria
Country
South Africa
Facility Name
248.596.27006 Boehringer Ingelheim Investigational Site
City
Richards Bay
Country
South Africa
Facility Name
248.596.34003 Hospital de Alcorcón. Departamento de Neurología
City
Alcorcon (Madrid)
Country
Spain
Facility Name
248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología
City
Barcelona
Country
Spain
Facility Name
248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología
City
Barcelona
Country
Spain
Facility Name
248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología
City
Barcelona
Country
Spain
Facility Name
248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología
City
Madrid
Country
Spain
Facility Name
248.596.34004 Hospital General de Catalunya. Departamento de Neurología
City
San Cugat del Valles (Barcelona)
Country
Spain
Facility Name
248.596.46004 Boehringer Ingelheim Investigational Site
City
Linköping
Country
Sweden
Facility Name
248.596.46001 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
248.596.46002 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
248.596.38004 Boehringer Ingelheim Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
248.596.38005 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
248.596.38002 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
248.596.38006 Boehringer Ingelheim Investigational Site
City
Simferopol
Country
Ukraine
Facility Name
248.596.38003 Boehringer Ingelheim Investigational Site
City
Vinnytzya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
20452823
Citation
Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.596_U08-2208-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.596_Literature.pdf
Description
Related Info

Learn more about this trial

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

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