Clinical trial NCT00321854: Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 535
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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);
* Patients who are currently pregnant or planning pregnancy during the study, or lactating;
* Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
* History of psychosis;
* A diagnosis of dementia

Primary outcomes:
measure: Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
timeFrame: Baseline and Month 15
Secondary outcomes:
measure: Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
timeFrame: Baseline and Month 3
measure: Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
timeFrame: Month 15
measure: Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
timeFrame: Baseline and Month 9
measure: Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
timeFrame: Baseline and Month 15
measure: Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
timeFrame: Baseline and Month 9
measure: Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
timeFrame: Month 1
measure: Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
timeFrame: Month 6
measure: Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
timeFrame: Month 9
measure: Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
timeFrame: Month 12
measure: Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
timeFrame: Month 15
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
timeFrame: Month 1
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
timeFrame: Month 6
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
timeFrame: Month 9
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
timeFrame: Month 12
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
timeFrame: Month 15
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
timeFrame: Month 1
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
timeFrame: Month 6
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
timeFrame: Month 9
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
timeFrame: Month 12
measure: Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
timeFrame: Month 15
measure: Percentage Change From Baseline in the Striatum Uptake at Month 15
timeFrame: Baseline and Month 15
measure: Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
timeFrame: Baseline and Month 15
measure: Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
timeFrame: Baseline and Month 15
measure: Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
timeFrame: Baseline and Month 15
measure: Clinically Significant Abnormalities in Vital Signs
timeFrame: Baseline and Month 15
Other outcomes:
Locations:
city: Brimingham
country: United States
facility: 248.595.0122 Boehringer Ingelheim Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: 248.595.0104 Boehringer Ingelheim Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: 248.595.0133 Boehringer Ingelheim Investigational Site
state: California
city: La Jolla
country: United States
facility: 248.595.0140 Boehringer Ingelheim Investigational Site
state: California
city: New Haven
country: United States
facility: 248.595.0112 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Bradenton
country: United States
facility: 248.595.0113 Boehringer Ingelheim Investigational Site
state: Florida
city: Gainesville
country: United States
facility: 248.595.0105 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 248.595.0119 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: 248.595.0124 Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: 248.595.0123 Boehringer Ingelheim Investigational Site
state: Florida
city: South Miami
country: United States
facility: 248.595.0109 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 248.595.0115 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 248.595.0106 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 248.595.0103 Boehringer Ingelheim Investigational Site
state: Georgia
city: Augusta
country: United States
facility: 248.595.0127 Boehringer Ingelheim Investigational Site
state: Georgia
city: Columbus
country: United States
facility: 248.595.0137 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 248.595.0101 Boehringer Ingelheim Investigational Site
state: Illinois
city: Elk Grove Village
country: United States
facility: 248.595.0111 Boehringer Ingelheim Investigational Site
state: Illinois
city: Scarbourough
country: United States
facility: 248.595.0131 Boehringer Ingelheim Investigational Site
state: Maine
city: Baltimore
country: United States
facility: 248.595.0134 Boehringer Ingelheim Investigational Site
state: Maryland
city: Worcester
country: United States
facility: 248.595.0141 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Traverse City
country: United States
facility: 248.595.0102 Boehringer Ingelheim Investigational Site
state: Michigan
city: New York
country: United States
facility: 248.595.0129 Boehringer Ingelheim Investigational Site
state: New York
city: Raleigh
country: United States
facility: 248.595.0139 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: 248.595.0136 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: 248.595.0120 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 248.595.0107 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 248.595.0118 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Warwick
country: United States
facility: 248.595.0114 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: 248.595.0116 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Houston
country: United States
facility: 248.595.0108 Boehringer Ingelheim Investigational Site
state: Texas
city: Kirkland
country: United States
facility: 248.595.0121 Boehringer Ingelheim Investigational Site
state: Washington
city: Bruck a. d. Mur
country: Austria
facility: 248.595.43005 Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: 248.595.43003 Boehringer Ingelheim Investigational Site
city: Innsbruck
country: Austria
facility: 248.595.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 248.595.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 248.595.43004 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 248.595.35803 Boehringer Ingelheim Investigational Site
city: Lahti
country: Finland
facility: 248.595.35804 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 248.595.35801 Boehringer Ingelheim Investigational Site
city: Aix en Provence
country: France
facility: 248.595.3306A Centre Hospitalier du Pays d'Aix
city: Aix en Provence
country: France
facility: 248.595.3306B Centre Hospitalier du Pays d'Aix
city: Aix en Provence
country: France
facility: 248.595.3306C Centre Hospitalier du Pays d'Aix
city: Clermont Ferrand
country: France
facility: 248.595.3301A Hôpital Gabriel Montpied
city: Clermont Ferrand
country: France
facility: 248.595.3301B Hôpital Gabriel Montpied
city: Evreux
country: France
facility: 248.595.3303A Cabinet Médical
city: Lille cedex
country: France
facility: 248.595.3307A Hôpital Roger Salengro
city: Lille cedex
country: France
facility: 248.595.3307B Hôpital Roger Salengro
city: Marseille cedex 05
country: France
facility: 248.595.3302A Hôpital La Timone
city: Marseille cedex 05
country: France
facility: 248.595.3302B Hôpital La Timone
city: Toulouse cedex 9
country: France
facility: 248.595.3305A Hôpital Purpan
city: Toulouse cedex 9
country: France
facility: 248.595.3305C Hôpital Purpan
city: Augsburg
country: Germany
facility: 248.595.49006 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 248.595.49008 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 248.595.49007 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 248.595.49011 Boehringer Ingelheim Investigational Site
city: Gera
country: Germany
facility: 248.595.49016 Boehringer Ingelheim Investigational Site
city: Göttingen
country: Germany
facility: 248.595.49009 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 248.595.49004 Boehringer Ingelheim Investigational Site
city: Hanau
country: Germany
facility: 248.595.49010 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 248.595.49005 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 248.595.49012 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 248.595.49001 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 248.595.49015 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 248.595.49014 Boehringer Ingelheim Investigational Site
city: Bari
country: Italy
facility: 248.595.39004 Università degli Studi di Bari
city: Bologna
country: Italy
facility: 248.595.39009 Ospedale di Bellaria
city: Grosseto
country: Italy
facility: 248.595.39005 Ospedale della Misericordia
city: Milano
country: Italy
facility: 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento
city: Milano
country: Italy
facility: 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena
city: Milano
country: Italy
facility: 248.595.39011 Ospedale S. Raffaele - IRCCS
city: Napoli
country: Italy
facility: 248.595.39002 Università Federico II
city: Pisa
country: Italy
facility: 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
city: Roma
country: Italy
facility: 248.595.39014 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 248.595.39006 Policlinico Universitario Molinette
city: Torino
country: Italy
facility: 248.595.39007 Ospedale Evangelico Valdese
city: Venezia Mestre
country: Italy
facility: 248.595.39013 Ospedale Umberto I
city: Viareggio
country: Italy
facility: 248.595.39003 Ospedale di Viareggio
city: Bunkyo-ku, Tokyo
country: Japan
facility: 248.595.81001 Juntendo University Hospital
city: Takamatsu, Kagawa
country: Japan
facility: 248.595.81002 Kagawa Prefectural Central Hospital
city: Alcorcon (Madrid)
country: Spain
facility: 248.595.34003 Hospital de Alcorcon
city: Barcelona
country: Spain
facility: 248.595.34001 Hospital Clinic i Provincial of Barcelona
city: Barcelona
country: Spain
facility: 248.595.34002 Nuevo Hospital de Sant Pau
city: Madrid
country: Spain
facility: 248.595.34004 Hospital 12 de Octubre
city: Tarrasa (Barcelona)
country: Spain
facility: 248.595.34005 Hospital Mutua de Terrassa
city: Jönköping
country: Sweden
facility: 248.595.46004 Boehringer Ingelheim Investigational Site
city: Linköping
country: Sweden
facility: 248.595.46006 Boehringer Ingelheim Investigational Site
city: Norrköping
country: Sweden
facility: 248.595.46005 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 248.595.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 248.595.46007 Boehringer Ingelheim Investigational Site
city: Örebro
country: Sweden
facility: 248.595.46002 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 248.595.44003 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 248.595.44008 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 248.595.44004 Boehringer Ingelheim Investigational Site
city: Newark
country: United Kingdom
facility: 248.595.44002 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 248.595.44001 Boehringer Ingelheim Investigational Site
city: North Shields
country: United Kingdom
facility: 248.595.44010 Boehringer Ingelheim Investigational Site
city: Romford
country: United Kingdom
facility: 248.595.44011 Boehringer Ingelheim Investigational Site
city: Stoke-on-Trent
country: United Kingdom
facility: 248.595.44005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.