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Pramipexole Versus Placebo in PD Patients With Depressive Symptoms
This study has been completed.
First Received: February 28, 2006   Last Updated: April 24, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00297778
  Purpose

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 aff ect 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, t here 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.


Condition Intervention Phase
Parkinson Disease
Depression
Drug: Pramipexole
Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Depression Parkinson's Disease
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint for this study is clinical response after 12 weeks of treatment, defined as a change in total score of baseline symptoms as measured by the BDI total score. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • changes from Baseline BDI 50 percent reduction SHAPS total score UPDRS II, III, IV QoL scales PDQ 39 and EQ 5D (CGI-I) VAS for pain adverse events Withdrawals due to AE Change in vital signs [ Time Frame: 12 weeks ]

Enrollment: 296
Study Start Date: March 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 15-item Geriatric Depression Scale (GDS) > or = 5
  2. 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-HCG pregnancy test at the Screening visit unless surgically sterile or last menstruation >or = 12 months prior to signing IC.
  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 6 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297778

  Hide Study Locations
Locations
Austria
248.596.43001 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
248.596.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
248.596.43003 Boehringer Ingelheim Investigational Site
Graz, Austria
248.596.43004 Boehringer Ingelheim Investigational Site
St. Pölten, Austria
248.596.43005 Boehringer Ingelheim Investigational Site
Linz, Austria
Finland
248.596.35801 Boehringer Ingelheim Investigational Site
Oulu, Finland
France
248.596.3303A Hôpital La Timone
Marseille cedex 5, France
248.596.3305A Hôpital du Haut Levêque
Pessac cédex, France
248.596.3305B Hôpital du Haut Levêque
Pessac cédex, France
248.596.3306A Hôpital Pierre Wertheimer
Bron cedex, France
248.596.3307A Hôpital Roger Salengro
Lille cedex, France
248.596.3301A Hôpital Guillaume et René Laennec
Saint Herblain, France
248.596.3302A Centre Hospitalier du Pays d'Aix
Aix en Provence, France
248.596.3302B Centre Hospitalier du Pays d'Aix
Aix en Provence cedex 1, France
248.596.3308A Hôpital Gabriel Montpied
Clermont Ferrand, France
248.596.3307B Hôpital Roger Salengro
Lille cedex, France
248.596.3307C Hôpital Roger Salengro
Lille cedex, France
248.596.3309A Cabinet Médical
Evreux, France
Germany
248.596.49001 Boehringer Ingelheim Investigational Site
Karlsruhe, Germany
248.596.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.596.49003 Boehringer Ingelheim Investigational Site
Bremerhaven, Germany
248.596.49004 Boehringer Ingelheim Investigational Site
Gera, Germany
248.596.49005 Boehringer Ingelheim Investigational Site
Marburg, Germany
248.596.49008 Boehringer Ingelheim Investigational Site
München, Germany
248.596.49014 Boehringer Ingelheim Investigational Site
Mittweida, Germany
248.596.49016 Boehringer Ingelheim Investigational Site
Köln, Germany
248.596.49012 Boehringer Ingelheim Investigational Site
Berlin-Steglitz, Germany
248.596.49013 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.596.49015 Boehringer Ingelheim Investigational Site
Berlin, Germany
Italy
248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"
Pescara, Italy
248.596.39002 Università degli studi di Genova
Genova, Italy
248.596.39003 Università degli studi di Napoli "Federico II"
Napoli, Italy
248.596.39004 Neurologia Ospedale della Misericordia
Grosseto, Italy
248.596.39005 Clinica Neurologica Policlinico G. Martino
Messina, Italy
248.596.39006 Neurologia Ospedale Evangelico Valdese
Torino, Italy
248.596.39007 Clinica Neurologica Policlinico Tor Vergata
Roma, Italy
248.596.39008 Clinica Neurologica I Policlinico di Catania
Catania, Italy
248.596.39009 Istituti Clinici di Perfezionamento
Milano, Italy
Netherlands
248.596.31002 Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
248.596.31001 Maasland Ziekenhuis
Sittard, Netherlands
248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA
's-Hertogenbosch, Netherlands
248.596.31005 Ziekenhuis Gooi-Noord
Blaricum, Netherlands
248.596.31004 Amphia ziekenhuis, Locatie Molengracht
Breda, Netherlands
248.596.31007 Afdeling neurologie
Amsterdam, Netherlands
Norway
248.596.47002 Boehringer Ingelheim Investigational Site
ARENDAL, Norway
248.596.47003 Boehringer Ingelheim Investigational Site
SANDVIKA, Norway
248.596.47004 Boehringer Ingelheim Investigational Site
LILLEHAMMER, Norway
Romania
248.596.40001 Boehringer Ingelheim Investigational Site
Cluj Napoca, Romania
248.596.40002 Boehringer Ingelheim Investigational Site
Iasi, 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
Bucharest, Romania
248.596.40006 Country Clinical Emergency Hospital
Targu-Mures, Romania
Russian Federation
248.596.70003 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
248.596.70004 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
248.596.70002 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
248.596.70001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
248.596.70005 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
South Africa
248.596.27001 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
248.596.27003 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
248.596.27004 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
248.596.27006 Boehringer Ingelheim Investigational Site
Richards Bay, South Africa
248.596.27007 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
248.596.27008 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
Spain
248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología
Barcelona, Spain
248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología
Barcelona, Spain
248.596.34003 Hospital de Alcorcón. Departamento de Neurología
Alcorcon (Madrid), Spain
248.596.34004 Hospital General de Catalunya. Departamento de Neurología
San Cugat del Valles (Barcelona), Spain
248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología
Barcelona, Spain
248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología
Madrid, Spain
Sweden
248.596.46001 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
248.596.46002 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
248.596.46004 Boehringer Ingelheim Investigational Site
Linköping, Sweden
Ukraine
248.596.38003 Boehringer Ingelheim Investigational Site
Vinnytzya, Ukraine
248.596.38002 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
248.596.38005 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
248.596.38006 Boehringer Ingelheim Investigational Site
Simferopol, Ukraine
248.596.38004 Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.596, Eudract 2005-003788-22
Study First Received: February 28, 2006
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00297778     History of Changes
Health Authority: Austria: Federal Office for Safety in Health Care;   Finland: National Agency for Medicines;   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)

Study placed in the following topic categories:
Neurotransmitter Agents
Depression
Ganglion Cysts
Antioxidants
Basal Ganglia Diseases
Central Nervous System Diseases
Dopamine Agonists
Depressive Disorder
Brain Diseases
Neurodegenerative Diseases
Pramipexol
Behavioral Symptoms
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Depression
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Protective Agents
Pharmacologic Actions
Pramipexol
Behavioral Symptoms
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 12, 2009