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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00321854
First received: May 3, 2006
Last updated: May 7, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: pramipexole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  • Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  • Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  • Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  • Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

  • 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 ] [ Designated as safety issue: No ]
    The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

  • 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 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    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)

  • Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 [ Time Frame: Month 15 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 [ Time Frame: Month 15 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 [ Time Frame: Month 15 ] [ Designated as safety issue: No ]
    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.

  • Percentage Change From Baseline in the Striatum Uptake at Month 15 [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
    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).

  • Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
  • Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
  • Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
  • Clinically Significant Abnormalities in Vital Signs [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]

Enrollment: 535
Study Start Date: May 2006
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321854

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

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00321854     History of Changes
Other Study ID Numbers: 248.595
Study First Received: May 3, 2006
Results First Received: December 18, 2009
Last Updated: May 7, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna, Austria
Finland: Finnish Medicines Agency
France: AFFSAPS
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Italy: Comitato Etico dell'Az. USL 12 di Viareggio - VIAREGGIO
Japan: Ministry of Health, Labor and Welfare
Spain: Spanish Agency for Medicines and Health Products
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden
United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 27, 2014