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

NCT00297778 | Completed Phase 4 Results

• 2 other identifiers: 248.596Eudract 2005-003788-22
• Study Type: interventional
• Target: 296
• Locations: 13 countries
• Sites: 77

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and Week 12

Secondary Outcomes (14)

• Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12

  Week 12

• Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12

  Baseline and Week 12

• Change From Baseline in the UPDRS Part II Total Score at Week 12

  Baseline and Week 12

Study Arms (2)

pramipexole

EXPERIMENTAL

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

Drug: Pramipexole

placebo

PLACEBO COMPARATOR

Placebo (matching) tablets

Other: Placebo

Interventions

Pramipexole DRUG

Dopamine agonist

pramipexole

Placebo OTHER

placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (77)

248.596.43003 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

248.596.43001 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

248.596.43005 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

248.596.43004 Boehringer Ingelheim Investigational Site

Sankt Pölten, Austria

Location

248.596.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

248.596.35801 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.596.3302A Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

248.596.3302B Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

248.596.3306A Hôpital Pierre Wertheimer

Bron, France

Location

248.596.3308A Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

248.596.3309A Cabinet Médical

Évreux, France

Location

248.596.3307A Hôpital Roger Salengro

Lille, France

Location

248.596.3307B Hôpital Roger Salengro

Lille, France

Location

248.596.3307C Hôpital Roger Salengro

Lille, France

Location

248.596.3303A Hôpital La Timone

Marseille, France

Location

248.596.3305A Hôpital du Haut Levêque

Pessac Cédex, France

Location

248.596.3305B Hôpital du Haut Levêque

Pessac Cédex, France

Location

248.596.3301A Hôpital Guillaume et René Laennec

Saint-Herblain, France

Location

248.596.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.596.49013 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.596.49015 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.596.49003 Boehringer Ingelheim Investigational Site

Bremerhaven, Germany

Location

248.596.49016 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

248.596.49004 Boehringer Ingelheim Investigational Site

Gera, Germany

Location

248.596.49001 Boehringer Ingelheim Investigational Site

Karlsruhe, Germany

Location

248.596.49005 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

248.596.49014 Boehringer Ingelheim Investigational Site

Mittweida, Germany

Location

248.596.49008 Boehringer Ingelheim Investigational Site

München, Germany

Location

248.596.49012 Boehringer Ingelheim Investigational Site

Steglitz, Germany

Location

248.596.39008 Clinica Neurologica I Policlinico di Catania

Catania, Italy

Location

248.596.39004 Neurologia Ospedale della Misericordia

Grosseto, Italy

Location

248.596.39005 Clinica Neurologica Policlinico G. Martino

Messina, Italy

Location

248.596.39009 Istituti Clinici di Perfezionamento

Milan, Italy

Location

248.596.39003 Università degli studi di Napoli "Federico II"

Napoli, Italy

Location

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

Pescara, Italy

Location

248.596.39007 Clinica Neurologica Policlinico Tor Vergata

Roma, Italy

Location

248.596.39006 Neurologia Ospedale Evangelico Valdese

Torino, Italy

Location

248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA

's-Hertogenbosch, Netherlands

Location

248.596.31007 Afdeling neurologie

Amsterdam, Netherlands

Location

248.596.31005 Ziekenhuis Gooi-Noord

Blaricum, Netherlands

Location

248.596.31004 Amphia ziekenhuis, Locatie Molengracht

Breda, Netherlands

Location

248.596.31002 Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

248.596.31001 Maasland Ziekenhuis

Sittard, Netherlands

Location

248.596.47002 Boehringer Ingelheim Investigational Site

Arendal, Norway

Location

248.596.47004 Boehringer Ingelheim Investigational Site

Lillehammer, Norway

Location

248.596.47003 Boehringer Ingelheim Investigational Site

Sandvika, Norway

Location

248.596.40003 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

248.596.40004 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

248.596.40005 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

248.596.40001 Boehringer Ingelheim Investigational Site

Cluj-Napoca, Romania

Location

248.596.40002 Boehringer Ingelheim Investigational Site

Iași, Romania

Location

248.596.40006 Country Clinical Emergency Hospital

Târgu Mureş, Romania

Location

248.596.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.596.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.596.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.596.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.596.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.596.27001 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

248.596.27003 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

248.596.27007 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

248.596.27008 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

248.596.27004 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

248.596.27006 Boehringer Ingelheim Investigational Site

Richards Bay, South Africa

Location

248.596.34003 Hospital de Alcorcón. Departamento de Neurología

Alcorcon (Madrid), Spain

Location

248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología

Barcelona, Spain

Location

248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología

Barcelona, Spain

Location

248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología

Barcelona, Spain

Location

248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología

Madrid, Spain

Location

248.596.34004 Hospital General de Catalunya. Departamento de Neurología

San Cugat Del Valles (Barcelona), Spain

Location

248.596.46004 Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

248.596.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

248.596.46002 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

248.596.38004 Boehringer Ingelheim Investigational Site

Donetsk, Ukraine

Location

248.596.38005 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

248.596.38002 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

248.596.38006 Boehringer Ingelheim Investigational Site

Simferopol, Ukraine

Location

248.596.38003 Boehringer Ingelheim Investigational Site

Vinnytzya, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 20452823 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 1, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Last Updated: June 9, 2014
• Results First Posted: September 24, 2009

Record last verified: 2014-04

Locations

IT (8); AU (5); NL (6); RO (6); NO (3); FR (12); DE (11); ZA (6); FI (1); UA (5); RU (5); SE (3); ES (6)