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

June 3, 2014 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • 248.596.43003 Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • 248.596.43001 Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • 248.596.43005 Boehringer Ingelheim Investigational Site
      • St. Pölten, Austria
        • 248.596.43004 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 248.596.43002 Boehringer Ingelheim Investigational Site
  • Finland
      • Oulu, Finland
        • 248.596.35801 Boehringer Ingelheim Investigational Site
  • France
      • Aix en Provence, France
        • 248.596.3302A Centre Hospitalier du Pays d'Aix
      • Aix en Provence cedex 1, France
        • 248.596.3302B Centre Hospitalier du Pays d'Aix
      • Bron cedex, France
        • 248.596.3306A Hôpital Pierre Wertheimer
      • Clermont Ferrand, France
        • 248.596.3308A Hôpital Gabriel Montpied
      • Evreux, France
        • 248.596.3309A Cabinet Médical
      • Lille cedex, France
        • 248.596.3307A Hôpital Roger Salengro
      • Lille cedex, France
        • 248.596.3307B Hôpital Roger Salengro
      • Lille cedex, France
        • 248.596.3307C Hôpital Roger Salengro
      • Marseille cedex 5, France
        • 248.596.3303A Hôpital La Timone
      • Pessac cédex, France
        • 248.596.3305A Hôpital du Haut Levêque
      • Pessac cédex, France
        • 248.596.3305B Hôpital du Haut Levêque
      • Saint Herblain, France
        • 248.596.3301A Hôpital Guillaume et René Laennec
  • Germany
      • Berlin, Germany
        • 248.596.49002 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 248.596.49013 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 248.596.49015 Boehringer Ingelheim Investigational Site
      • Berlin-Steglitz, Germany
        • 248.596.49012 Boehringer Ingelheim Investigational Site
      • Bremerhaven, Germany
        • 248.596.49003 Boehringer Ingelheim Investigational Site
      • Gera, Germany
        • 248.596.49004 Boehringer Ingelheim Investigational Site
      • Karlsruhe, Germany
        • 248.596.49001 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 248.596.49016 Boehringer Ingelheim Investigational Site
      • Marburg, Germany
        • 248.596.49005 Boehringer Ingelheim Investigational Site
      • Mittweida, Germany
        • 248.596.49014 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 248.596.49008 Boehringer Ingelheim Investigational Site
  • Italy
      • Catania, Italy
        • 248.596.39008 Clinica Neurologica I Policlinico di Catania
      • Grosseto, Italy
        • 248.596.39004 Neurologia Ospedale della Misericordia
      • Messina, Italy
        • 248.596.39005 Clinica Neurologica Policlinico G. Martino
      • Milano, Italy
        • 248.596.39009 Istituti Clinici di Perfezionamento
      • Napoli, Italy
        • 248.596.39003 Università degli studi di Napoli "Federico II"
      • Pescara, Italy
        • 248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"
      • Roma, Italy
        • 248.596.39007 Clinica Neurologica Policlinico Tor Vergata
      • Torino, Italy
        • 248.596.39006 Neurologia Ospedale Evangelico Valdese
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • 248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA
      • Amsterdam, Netherlands
        • 248.596.31007 Afdeling neurologie
      • Blaricum, Netherlands
        • 248.596.31005 Ziekenhuis Gooi-Noord
      • Breda, Netherlands
        • 248.596.31004 Amphia ziekenhuis, Locatie Molengracht
      • Nijmegen, Netherlands
        • 248.596.31002 Canisius-Wilhelmina Ziekenhuis
      • Sittard, Netherlands
        • 248.596.31001 Maasland Ziekenhuis
  • Norway
      • Arendal, Norway
        • 248.596.47002 Boehringer Ingelheim Investigational Site
      • Lillehammer, Norway
        • 248.596.47004 Boehringer Ingelheim Investigational Site
      • Sandvika, Norway
        • 248.596.47003 Boehringer Ingelheim Investigational Site
  • Romania
      • Bucharest, Romania
        • 248.596.40003 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 248.596.40004 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 248.596.40005 Boehringer Ingelheim Investigational Site
      • Cluj Napoca, Romania
        • 248.596.40001 Boehringer Ingelheim Investigational Site
      • Iasi, Romania
        • 248.596.40002 Boehringer Ingelheim Investigational Site
      • Targu-Mures, Romania
        • 248.596.40006 Country Clinical Emergency Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • 248.596.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 248.596.70003 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 248.596.70002 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 248.596.70004 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 248.596.70005 Boehringer Ingelheim Investigational Site
  • South Africa
      • Cape Town, South Africa
        • 248.596.27001 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 248.596.27003 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 248.596.27007 Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa
        • 248.596.27008 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 248.596.27004 Boehringer Ingelheim Investigational Site
      • Richards Bay, South Africa
        • 248.596.27006 Boehringer Ingelheim Investigational Site
  • Spain
      • Alcorcon (Madrid), Spain
        • 248.596.34003 Hospital de Alcorcón. Departamento de Neurología
      • Barcelona, Spain
        • 248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología
      • Barcelona, Spain
        • 248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología
      • Barcelona, Spain
        • 248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología
      • Madrid, Spain
        • 248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología
      • San Cugat del Valles (Barcelona), Spain
        • 248.596.34004 Hospital General de Catalunya. Departamento de Neurología
  • Sweden
      • Linköping, Sweden
        • 248.596.46004 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 248.596.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 248.596.46002 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Donetsk, Ukraine
        • 248.596.38004 Boehringer Ingelheim Investigational Site
      • Kharkiv, Ukraine
        • 248.596.38005 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 248.596.38002 Boehringer Ingelheim Investigational Site
      • Simferopol, Ukraine
        • 248.596.38006 Boehringer Ingelheim Investigational Site
      • Vinnytzya, Ukraine
        • 248.596.38003 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 15-item Geriatric Depression Scale (GDS) > or = 5
  2. Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2
  3. Folsteins Mini-Mental State Examination (MMSE) score > 24
  4. Male or female patient with PD (UK PD Brain Bank criteria).
  5. Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms .
  6. Male or female patients aged 30 - 80 years.
  7. Ability to provide written informed consent.
  8. 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.
  9. Women of childbearing potential must be using an accepted contraceptive.
  10. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
  2. History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential.
  3. Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
  4. History of PD stereotactic brain surgery.
  5. Surgery within 180 days of randomization that would negatively impact the patients participation in the study.
  6. History of active epilepsy within the past year.
  7. Current psychotherapy or behavior therapy while participating the trial
  8. Symptomatic orthostatic hypotension prior to randomization.
  9. Malignant melanoma or history of previously treated malignant melanoma.
  10. Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months.
  11. Patients who have received dopamine agonists within the past 30 days
  12. Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1).
  13. Patients who are currently lactating.
  14. Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
  15. Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
  16. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pramipexole
A daily dose of pramipexole 0.125 mg t.i.d.; titration-to-response up to 1.0 mg t.i.d.
Drug: Pramipexole
Dopamine agonist
Placebo Comparator: placebo
Placebo (matching) tablets
Other: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
Time Frame: Week 12
BDI clinical response was defined as a reduction of ≥50% from baseline
Week 12
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
The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
Baseline and Week 12
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
Time Frame: Baseline and Week 12
The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
Baseline and Week 12
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
The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
Baseline and Week 12
Change From Baseline in the UPDRS Part II Total Score at Week 12
Time Frame: Baseline and 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)
Baseline and Week 12
Change From Baseline in the UPDRS Part III Total Score at Week 12
Time Frame: Baseline and 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)
Baseline and Week 12
Change From Baseline in the UPDRS Part II+III Total Score at Week 12
Time Frame: Baseline and 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)
Baseline and Week 12
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
Time Frame: 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)
Week 12
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
Time Frame: Baseline and 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)
Baseline and Week 12
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
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)
Baseline and Week 12
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
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).
Baseline and Week 12
Change From Baseline in the UPDRS Part I Total Score at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change From Baseline in the UPDRS Part IV Total Score at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.596
  • Eudract 2005-003788-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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