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

May 7, 2014 updated by: Boehringer Ingelheim

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

535

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bruck a. d. Mur, Austria
        • 248.595.43005 Boehringer Ingelheim Investigational Site
      • Graz, Austria
        • 248.595.43003 Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • 248.595.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 248.595.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 248.595.43004 Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland
        • 248.595.35803 Boehringer Ingelheim Investigational Site
      • Lahti, Finland
        • 248.595.35804 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 248.595.35801 Boehringer Ingelheim Investigational Site
  • France
      • Aix en Provence, France
        • 248.595.3306A Centre Hospitalier du Pays d'Aix
      • Aix en Provence, France
        • 248.595.3306B Centre Hospitalier du Pays d'Aix
      • Aix en Provence, France
        • 248.595.3306C Centre Hospitalier du Pays d'Aix
      • Clermont Ferrand, France
        • 248.595.3301A Hôpital Gabriel Montpied
      • Clermont Ferrand, France
        • 248.595.3301B Hôpital Gabriel Montpied
      • Evreux, France
        • 248.595.3303A Cabinet Médical
      • Lille cedex, France
        • 248.595.3307A Hôpital Roger Salengro
      • Lille cedex, France
        • 248.595.3307B Hôpital Roger Salengro
      • Marseille cedex 05, France
        • 248.595.3302A Hôpital La Timone
      • Marseille cedex 05, France
        • 248.595.3302B Hôpital La Timone
      • Toulouse cedex 9, France
        • 248.595.3305A Hôpital Purpan
      • Toulouse cedex 9, France
        • 248.595.3305C Hôpital Purpan
  • Germany
      • Augsburg, Germany
        • 248.595.49006 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 248.595.49008 Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • 248.595.49007 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 248.595.49011 Boehringer Ingelheim Investigational Site
      • Gera, Germany
        • 248.595.49016 Boehringer Ingelheim Investigational Site
      • Göttingen, Germany
        • 248.595.49009 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 248.595.49004 Boehringer Ingelheim Investigational Site
      • Hanau, Germany
        • 248.595.49010 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 248.595.49005 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 248.595.49012 Boehringer Ingelheim Investigational Site
      • Marburg, Germany
        • 248.595.49001 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 248.595.49015 Boehringer Ingelheim Investigational Site
      • Tübingen, Germany
        • 248.595.49014 Boehringer Ingelheim Investigational Site
  • Italy
      • Bari, Italy
        • 248.595.39004 Università degli Studi di Bari
      • Bologna, Italy
        • 248.595.39009 Ospedale di Bellaria
      • Grosseto, Italy
        • 248.595.39005 Ospedale della Misericordia
      • Milano, Italy
        • 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento
      • Milano, Italy
        • 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena
      • Milano, Italy
        • 248.595.39011 Ospedale S. Raffaele - IRCCS
      • Napoli, Italy
        • 248.595.39002 Università Federico II
      • Pisa, Italy
        • 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
      • Roma, Italy
        • 248.595.39014 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 248.595.39006 Policlinico Universitario Molinette
      • Torino, Italy
        • 248.595.39007 Ospedale Evangelico Valdese
      • Venezia Mestre, Italy
        • 248.595.39013 Ospedale Umberto I
      • Viareggio, Italy
        • 248.595.39003 Ospedale di Viareggio
  • Japan
      • Bunkyo-ku, Tokyo, Japan
        • 248.595.81001 Juntendo University Hospital
      • Takamatsu, Kagawa, Japan
        • 248.595.81002 Kagawa Prefectural Central Hospital
  • Spain
      • Alcorcon (Madrid), Spain
        • 248.595.34003 Hospital de Alcorcon
      • Barcelona, Spain
        • 248.595.34001 Hospital Clinic i Provincial of Barcelona
      • Barcelona, Spain
        • 248.595.34002 Nuevo Hospital de Sant Pau
      • Madrid, Spain
        • 248.595.34004 Hospital 12 de Octubre
      • Tarrasa (Barcelona), Spain
        • 248.595.34005 Hospital Mutua de Terrassa
  • Sweden
      • Jönköping, Sweden
        • 248.595.46004 Boehringer Ingelheim Investigational Site
      • Linköping, Sweden
        • 248.595.46006 Boehringer Ingelheim Investigational Site
      • Norrköping, Sweden
        • 248.595.46005 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 248.595.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 248.595.46007 Boehringer Ingelheim Investigational Site
      • Örebro, Sweden
        • 248.595.46002 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom
        • 248.595.44003 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 248.595.44008 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 248.595.44004 Boehringer Ingelheim Investigational Site
      • Newark, United Kingdom
        • 248.595.44002 Boehringer Ingelheim Investigational Site
      • Newcastle upon Tyne, United Kingdom
        • 248.595.44001 Boehringer Ingelheim Investigational Site
      • North Shields, United Kingdom
        • 248.595.44010 Boehringer Ingelheim Investigational Site
      • Romford, United Kingdom
        • 248.595.44011 Boehringer Ingelheim Investigational Site
      • Stoke-on-Trent, United Kingdom
        • 248.595.44005 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Brimingham, Alabama, United States
        • 248.595.0122 Boehringer Ingelheim Investigational Site
    • Arizona
      • Scottsdale, Arizona, United States
        • 248.595.0104 Boehringer Ingelheim Investigational Site
    • California
      • La Jolla, California, United States
        • 248.595.0133 Boehringer Ingelheim Investigational Site
      • La Jolla, California, United States
        • 248.595.0140 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States
        • 248.595.0112 Boehringer Ingelheim Investigational Site
    • Florida
      • Bradenton, Florida, United States
        • 248.595.0113 Boehringer Ingelheim Investigational Site
      • Gainesville, Florida, United States
        • 248.595.0105 Boehringer Ingelheim Investigational Site
      • Hollywood, Florida, United States
        • 248.595.0119 Boehringer Ingelheim Investigational Site
      • Palm Beach Gardens, Florida, United States
        • 248.595.0124 Boehringer Ingelheim Investigational Site
      • Panama City, Florida, United States
        • 248.595.0123 Boehringer Ingelheim Investigational Site
      • South Miami, Florida, United States
        • 248.595.0109 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 248.595.0115 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 248.595.0106 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 248.595.0103 Boehringer Ingelheim Investigational Site
      • Augusta, Georgia, United States
        • 248.595.0127 Boehringer Ingelheim Investigational Site
      • Columbus, Georgia, United States
        • 248.595.0137 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 248.595.0101 Boehringer Ingelheim Investigational Site
      • Elk Grove Village, Illinois, United States
        • 248.595.0111 Boehringer Ingelheim Investigational Site
    • Maine
      • Scarbourough, Maine, United States
        • 248.595.0131 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 248.595.0134 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States
        • 248.595.0141 Boehringer Ingelheim Investigational Site
    • Michigan
      • Traverse City, Michigan, United States
        • 248.595.0102 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 248.595.0129 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • 248.595.0139 Boehringer Ingelheim Investigational Site
      • Winston Salem, North Carolina, United States
        • 248.595.0136 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • 248.595.0120 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 248.595.0107 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 248.595.0118 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States
        • 248.595.0114 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States
        • 248.595.0116 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • 248.595.0108 Boehringer Ingelheim Investigational Site
    • Washington
      • Kirkland, Washington, United States
        • 248.595.0121 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early Pramipexole
Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Drug: pramipexole
EXPERIMENTAL: Delayed Pramipexole
Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Drug: pramipexole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Time Frame: Baseline and 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
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Time Frame: Baseline and Month 9
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 9
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Time Frame: Baseline and Month 6
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 6
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Time Frame: Baseline and Month 3
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 3
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Time Frame: Baseline and Month 9
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Time Frame: Baseline and Month 6
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Time Frame: Baseline and Month 3
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Time Frame: Baseline and Month 9
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Time Frame: Baseline and Month 6
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Time Frame: Baseline and Month 3
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Time Frame: Baseline and Month 9
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Time Frame: Baseline and Month 6
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Time Frame: Baseline and Month 3
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Time Frame: Baseline and Month 15
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Time Frame: Baseline and Month 9
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Time Frame: Baseline and Month 6
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Time Frame: Baseline and Month 3
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Baseline and Month 3
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
Time Frame: Month 15
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.
Month 15
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Time Frame: Baseline and Month 15
The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).
Baseline and Month 15
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Time Frame: Baseline and Month 15
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Baseline and Month 15
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Time Frame: Baseline and Month 9
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Baseline and Month 9
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Time Frame: Baseline and Month 6
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Baseline and Month 6
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Time Frame: Baseline and Month 3
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Baseline and Month 3
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Time Frame: Baseline and Month 15
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Baseline and Month 15
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Time Frame: Baseline and Month 9
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Baseline and Month 9
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Time Frame: Baseline and Month 15
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Baseline and Month 15
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Time Frame: Baseline and Month 9
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Baseline and Month 9
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Time Frame: Baseline and Month 15
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Baseline and Month 15
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Time Frame: Baseline and Month 9
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Baseline and Month 9
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Time Frame: Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Month 1
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
Time Frame: Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Month 6
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
Time Frame: Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Month 9
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
Time Frame: Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Month 12
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
Time Frame: Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Month 15
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
Time Frame: Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Month 1
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
Time Frame: Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Month 6
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
Time Frame: Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Month 9
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
Time Frame: Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Month 12
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
Time Frame: Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Month 15
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
Time Frame: Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Month 1
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
Time Frame: Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Month 6
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
Time Frame: Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Month 9
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
Time Frame: Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Month 12
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
Time Frame: Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Month 15
Percentage Change From Baseline in the Striatum Uptake at Month 15
Time Frame: Baseline and Month 15
The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).
Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Time Frame: Baseline and Month 15
Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Time Frame: Baseline and Month 15
Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Time Frame: Baseline and Month 15
Baseline and Month 15
Clinically Significant Abnormalities in Vital Signs
Time Frame: Baseline and Month 15
Baseline and Month 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 3, 2006

First Posted (ESTIMATE)

May 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.595

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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