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

NCT ID: NCT00297778

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31

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.

Conditions

Parkinson Disease; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

pramipexole

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

Group Type: EXPERIMENTAL

Pramipexole

Intervention Type: DRUG

Dopamine agonist

placebo

Placebo (matching) tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Pramipexole

Dopamine agonist

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

248.596.43003 Boehringer Ingelheim Investigational Site

Graz, , Austria

248.596.43001 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

248.596.43005 Boehringer Ingelheim Investigational Site

Linz, , Austria

248.596.43004 Boehringer Ingelheim Investigational Site

Sankt Pölten, , Austria

248.596.43002 Boehringer Ingelheim Investigational Site

Vienna, , Austria

248.596.35801 Boehringer Ingelheim Investigational Site

Oulu, , Finland

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, , France

248.596.3306A Hôpital Pierre Wertheimer

Bron, , France

248.596.3308A Hôpital Gabriel Montpied

Clermont-Ferrand, , France

248.596.3309A Cabinet Médical

Évreux, , France

248.596.3307A Hôpital Roger Salengro

Lille, , France

248.596.3307B Hôpital Roger Salengro

Lille, , France

248.596.3307C Hôpital Roger Salengro

Lille, , France

248.596.3303A Hôpital La Timone

Marseille, , France

248.596.3305A Hôpital du Haut Levêque

Pessac Cédex, , France

248.596.3305B Hôpital du Haut Levêque

Pessac Cédex, , France

248.596.3301A Hôpital Guillaume et René Laennec

Saint-Herblain, , France

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, , Germany

248.596.49003 Boehringer Ingelheim Investigational Site

Bremerhaven, , Germany

248.596.49016 Boehringer Ingelheim Investigational Site

Cologne, , Germany

248.596.49004 Boehringer Ingelheim Investigational Site

Gera, , Germany

248.596.49001 Boehringer Ingelheim Investigational Site

Karlsruhe, , Germany

248.596.49005 Boehringer Ingelheim Investigational Site

Marburg, , Germany

248.596.49014 Boehringer Ingelheim Investigational Site

Mittweida, , Germany

248.596.49008 Boehringer Ingelheim Investigational Site

München, , Germany

248.596.49012 Boehringer Ingelheim Investigational Site

Steglitz, , Germany

248.596.39008 Clinica Neurologica I Policlinico di Catania

Catania, , Italy

248.596.39004 Neurologia Ospedale della Misericordia

Grosseto, , Italy

248.596.39005 Clinica Neurologica Policlinico G. Martino

Messina, , Italy

248.596.39009 Istituti Clinici di Perfezionamento

Milan, , Italy

248.596.39003 Università degli studi di Napoli "Federico II"

Napoli, , Italy

248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"

Pescara, , Italy

248.596.39007 Clinica Neurologica Policlinico Tor Vergata

Roma, , Italy

248.596.39006 Neurologia Ospedale Evangelico Valdese

Torino, , Italy

248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA

's-Hertogenbosch, , Netherlands

248.596.31007 Afdeling neurologie

Amsterdam, , Netherlands

248.596.31005 Ziekenhuis Gooi-Noord

Blaricum, , Netherlands

248.596.31004 Amphia ziekenhuis, Locatie Molengracht

Breda, , Netherlands

248.596.31002 Canisius-Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

248.596.31001 Maasland Ziekenhuis

Sittard, , Netherlands

248.596.47002 Boehringer Ingelheim Investigational Site

Arendal, , Norway

248.596.47004 Boehringer Ingelheim Investigational Site

Lillehammer, , Norway

248.596.47003 Boehringer Ingelheim Investigational Site

Sandvika, , Norway

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

248.596.40001 Boehringer Ingelheim Investigational Site

Cluj-Napoca, , Romania

248.596.40002 Boehringer Ingelheim Investigational Site

Iași, , Romania

248.596.40006 Country Clinical Emergency Hospital

Târgu Mureş, , Romania

248.596.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

248.596.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

248.596.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

248.596.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

248.596.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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

Cape Town, , South Africa

248.596.27008 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

248.596.27004 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

248.596.27006 Boehringer Ingelheim Investigational Site

Richards Bay, , South Africa

248.596.34003 Hospital de Alcorcón. Departamento de Neurología

Alcorcon (Madrid), , 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

Barcelona, , Spain

248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología

Madrid, , Spain

248.596.34004 Hospital General de Catalunya. Departamento de Neurología

San Cugat Del Valles (Barcelona), , Spain

248.596.46004 Boehringer Ingelheim Investigational Site

Linköping, , Sweden

248.596.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

248.596.46002 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

248.596.38004 Boehringer Ingelheim Investigational Site

Donetsk, , Ukraine

248.596.38005 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

248.596.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

248.596.38006 Boehringer Ingelheim Investigational Site

Simferopol, , Ukraine

248.596.38003 Boehringer Ingelheim Investigational Site

Vinnytzya, , Ukraine

Countries

Austria; Finland; France; Germany; Italy; Netherlands; Norway; Romania; Russia; South Africa; Spain; Sweden; Ukraine

References

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.

Reference Type: DERIVED

PMID: 20452823 (View on PubMed)

Related Links

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.596_Literature.pdf

Related Info

Other Identifiers

Eudract 2005-003788-22

Identifier Type: -

Identifier Source: secondary_id

248.596

Identifier Type: -

Identifier Source: org_study_id