Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

NCT00321854 | Completed Phase 4 Results

• 1 other identifier: 248.595
• Study Type: interventional
• Target: 535
• Locations: 10 countries
• Sites: 99

Brief Summary

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15

  The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

  Baseline and Month 15

Secondary Outcomes (56)

• Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15

  Baseline and Month 15

• Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9

  Baseline and Month 9

• Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6

  Baseline and Month 6

• Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3

  Baseline and Month 3

• Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15

  Baseline and Month 15

Study Arms (2)

Early Pramipexole

EXPERIMENTAL

Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).

Drug: pramipexole

Delayed Pramipexole

EXPERIMENTAL

Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).

Drug: pramipexole

Interventions

pramipexole DRUG

Delayed Pramipexole; Early Pramipexole

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
• Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
• Parkinsons disease newly diagnosed within the past 2 years;
• Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
• Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and 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 or complications with pramipexole (PPX) or its excipients;
• Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
• The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
• The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
• If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
• The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
• The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
• The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
• History of stereotactic brain surgery;
• Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
• History of active epilepsy (i.e., occurrence of a seizure) within the past year;
• Symptomatic orthostatic hypotension prior to randomization;
• Malignant melanoma or history of previously treated malignant melanoma;
• Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
• Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (99)

248.595.0122 Boehringer Ingelheim Investigational Site

Brimingham, Alabama, United States

Location

248.595.0104 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Location

248.595.0133 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

248.595.0140 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

248.595.0112 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

Location

248.595.0113 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Location

248.595.0105 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Location

248.595.0119 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

248.595.0124 Boehringer Ingelheim Investigational Site

Palm Beach Gardens, Florida, United States

Location

248.595.0123 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

248.595.0109 Boehringer Ingelheim Investigational Site

South Miami, Florida, United States

Location

248.595.0115 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

248.595.0106 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

248.595.0103 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

248.595.0127 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

248.595.0137 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

248.595.0101 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.595.0111 Boehringer Ingelheim Investigational Site

Elk Grove Village, Illinois, United States

Location

248.595.0131 Boehringer Ingelheim Investigational Site

Scarbourough, Maine, United States

Location

248.595.0134 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

248.595.0141 Boehringer Ingelheim Investigational Site

Worcester, Massachusetts, United States

Location

248.595.0102 Boehringer Ingelheim Investigational Site

Traverse City, Michigan, United States

Location

248.595.0129 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

248.595.0139 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

248.595.0136 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

248.595.0120 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

248.595.0107 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

248.595.0118 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

248.595.0114 Boehringer Ingelheim Investigational Site

Warwick, Rhode Island, United States

Location

248.595.0116 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

248.595.0108 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

248.595.0121 Boehringer Ingelheim Investigational Site

Kirkland, Washington, United States

Location

248.595.43005 Boehringer Ingelheim Investigational Site

Bruck A. D. Mur, Austria

Location

248.595.43003 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

248.595.43001 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

248.595.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

248.595.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

248.595.35803 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

248.595.35804 Boehringer Ingelheim Investigational Site

Lahti, Finland

Location

248.595.35801 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.595.3306A Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

248.595.3306B Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

248.595.3306C Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

248.595.3301A Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

248.595.3301B Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

248.595.3303A Cabinet Médical

Évreux, France

Location

248.595.3307A Hôpital Roger Salengro

Lille, France

Location

248.595.3307B Hôpital Roger Salengro

Lille, France

Location

248.595.3302A Hôpital La Timone

Marseille, France

Location

248.595.3302B Hôpital La Timone

Marseille, France

Location

248.595.3305A Hôpital Purpan

Toulouse, France

Location

248.595.3305C Hôpital Purpan

Toulouse, France

Location

248.595.49006 Boehringer Ingelheim Investigational Site

Augsburg, Germany

Location

248.595.49008 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.595.49007 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

248.595.49011 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

248.595.49016 Boehringer Ingelheim Investigational Site

Gera, Germany

Location

248.595.49009 Boehringer Ingelheim Investigational Site

Göttingen, Germany

Location

248.595.49004 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

248.595.49010 Boehringer Ingelheim Investigational Site

Hanau, Germany

Location

248.595.49005 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

248.595.49012 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

248.595.49001 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

248.595.49015 Boehringer Ingelheim Investigational Site

München, Germany

Location

248.595.49014 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

248.595.39004 Università degli Studi di Bari

Bari, Italy

Location

248.595.39009 Ospedale di Bellaria

Bologna, Italy

Location

248.595.39005 Ospedale della Misericordia

Grosseto, Italy

Location

248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento

Milan, Italy

Location

248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena

Milan, Italy

Location

248.595.39011 Ospedale S. Raffaele - IRCCS

Milan, Italy

Location

248.595.39002 Università Federico II

Napoli, Italy

Location

248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa

Pisa, Italy

Location

248.595.39014 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

248.595.39006 Policlinico Universitario Molinette

Torino, Italy

Location

248.595.39007 Ospedale Evangelico Valdese

Torino, Italy

Location

248.595.39013 Ospedale Umberto I

Venezia Mestre, Italy

Location

248.595.39003 Ospedale di Viareggio

Viareggio, Italy

Location

248.595.81001 Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Location

248.595.81002 Kagawa Prefectural Central Hospital

Takamatsu, Kagawa, Japan

Location

248.595.34003 Hospital de Alcorcon

Alcorcon (Madrid), Spain

Location

248.595.34001 Hospital Clinic i Provincial of Barcelona

Barcelona, Spain

Location

248.595.34002 Nuevo Hospital de Sant Pau

Barcelona, Spain

Location

248.595.34004 Hospital 12 de Octubre

Madrid, Spain

Location

248.595.34005 Hospital Mutua de Terrassa

Tarrasa (Barcelona), Spain

Location

248.595.46004 Boehringer Ingelheim Investigational Site

Jönköping, Sweden

Location

248.595.46006 Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

248.595.46005 Boehringer Ingelheim Investigational Site

Norrköping, Sweden

Location

248.595.46002 Boehringer Ingelheim Investigational Site

Örebro, Sweden

Location

248.595.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

248.595.46007 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

248.595.44003 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

248.595.44008 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

248.595.44004 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

248.595.44002 Boehringer Ingelheim Investigational Site

Newark, United Kingdom

Location

248.595.44001 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

248.595.44010 Boehringer Ingelheim Investigational Site

North Shields, United Kingdom

Location

248.595.44011 Boehringer Ingelheim Investigational Site

Romford, United Kingdom

Location

248.595.44005 Boehringer Ingelheim Investigational Site

Stoke-on-Trent, United Kingdom

Location

Related Publications (1)

• Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31.

  PMID: 23726851 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

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

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 Call Center
• 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: May 3, 2006
• First Posted: May 4, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2009
• Last Updated: May 16, 2014
• Results First Posted: January 26, 2010

Record last verified: 2014-03

Locations

FI (3); DE (13); US (32); FR (12); SE (6); JP (2); AU (5); IT (13); ES (5); GB (8)