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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pramipexole
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 248.595.0122 Boehringer Ingelheim Investigational Site
  • 248.595.0104 Boehringer Ingelheim Investigational Site
  • 248.595.0133 Boehringer Ingelheim Investigational Site
  • 248.595.0140 Boehringer Ingelheim Investigational Site
  • 248.595.0112 Boehringer Ingelheim Investigational Site
  • 248.595.0113 Boehringer Ingelheim Investigational Site
  • 248.595.0105 Boehringer Ingelheim Investigational Site
  • 248.595.0119 Boehringer Ingelheim Investigational Site
  • 248.595.0124 Boehringer Ingelheim Investigational Site
  • 248.595.0123 Boehringer Ingelheim Investigational Site
  • 248.595.0109 Boehringer Ingelheim Investigational Site
  • 248.595.0115 Boehringer Ingelheim Investigational Site
  • 248.595.0106 Boehringer Ingelheim Investigational Site
  • 248.595.0103 Boehringer Ingelheim Investigational Site
  • 248.595.0127 Boehringer Ingelheim Investigational Site
  • 248.595.0137 Boehringer Ingelheim Investigational Site
  • 248.595.0101 Boehringer Ingelheim Investigational Site
  • 248.595.0111 Boehringer Ingelheim Investigational Site
  • 248.595.0131 Boehringer Ingelheim Investigational Site
  • 248.595.0134 Boehringer Ingelheim Investigational Site
  • 248.595.0141 Boehringer Ingelheim Investigational Site
  • 248.595.0102 Boehringer Ingelheim Investigational Site
  • 248.595.0129 Boehringer Ingelheim Investigational Site
  • 248.595.0139 Boehringer Ingelheim Investigational Site
  • 248.595.0136 Boehringer Ingelheim Investigational Site
  • 248.595.0120 Boehringer Ingelheim Investigational Site
  • 248.595.0107 Boehringer Ingelheim Investigational Site
  • 248.595.0118 Boehringer Ingelheim Investigational Site
  • 248.595.0114 Boehringer Ingelheim Investigational Site
  • 248.595.0116 Boehringer Ingelheim Investigational Site
  • 248.595.0108 Boehringer Ingelheim Investigational Site
  • 248.595.0121 Boehringer Ingelheim Investigational Site
  • 248.595.43005 Boehringer Ingelheim Investigational Site
  • 248.595.43003 Boehringer Ingelheim Investigational Site
  • 248.595.43001 Boehringer Ingelheim Investigational Site
  • 248.595.43002 Boehringer Ingelheim Investigational Site
  • 248.595.43004 Boehringer Ingelheim Investigational Site
  • 248.595.35803 Boehringer Ingelheim Investigational Site
  • 248.595.35804 Boehringer Ingelheim Investigational Site
  • 248.595.35801 Boehringer Ingelheim Investigational Site
  • 248.595.3306A Centre Hospitalier du Pays d'Aix
  • 248.595.3306B Centre Hospitalier du Pays d'Aix
  • 248.595.3306C Centre Hospitalier du Pays d'Aix
  • 248.595.3301A Hôpital Gabriel Montpied
  • 248.595.3301B Hôpital Gabriel Montpied
  • 248.595.3303A Cabinet Médical
  • 248.595.3307A Hôpital Roger Salengro
  • 248.595.3307B Hôpital Roger Salengro
  • 248.595.3302A Hôpital La Timone
  • 248.595.3302B Hôpital La Timone
  • 248.595.3305A Hôpital Purpan
  • 248.595.3305C Hôpital Purpan
  • 248.595.49006 Boehringer Ingelheim Investigational Site
  • 248.595.49008 Boehringer Ingelheim Investigational Site
  • 248.595.49007 Boehringer Ingelheim Investigational Site
  • 248.595.49011 Boehringer Ingelheim Investigational Site
  • 248.595.49016 Boehringer Ingelheim Investigational Site
  • 248.595.49009 Boehringer Ingelheim Investigational Site
  • 248.595.49004 Boehringer Ingelheim Investigational Site
  • 248.595.49010 Boehringer Ingelheim Investigational Site
  • 248.595.49005 Boehringer Ingelheim Investigational Site
  • 248.595.49012 Boehringer Ingelheim Investigational Site
  • 248.595.49001 Boehringer Ingelheim Investigational Site
  • 248.595.49015 Boehringer Ingelheim Investigational Site
  • 248.595.49014 Boehringer Ingelheim Investigational Site
  • 248.595.39004 Università degli Studi di Bari
  • 248.595.39009 Ospedale di Bellaria
  • 248.595.39005 Ospedale della Misericordia
  • 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento
  • 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena
  • 248.595.39011 Ospedale S. Raffaele - IRCCS
  • 248.595.39002 Università Federico II
  • 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
  • 248.595.39014 Boehringer Ingelheim Investigational Site
  • 248.595.39006 Policlinico Universitario Molinette
  • 248.595.39007 Ospedale Evangelico Valdese
  • 248.595.39013 Ospedale Umberto I
  • 248.595.39003 Ospedale di Viareggio
  • 248.595.81001 Juntendo University Hospital
  • 248.595.81002 Kagawa Prefectural Central Hospital
  • 248.595.34003 Hospital de Alcorcon
  • 248.595.34001 Hospital Clinic i Provincial of Barcelona
  • 248.595.34002 Nuevo Hospital de Sant Pau
  • 248.595.34004 Hospital 12 de Octubre
  • 248.595.34005 Hospital Mutua de Terrassa
  • 248.595.46004 Boehringer Ingelheim Investigational Site
  • 248.595.46006 Boehringer Ingelheim Investigational Site
  • 248.595.46005 Boehringer Ingelheim Investigational Site
  • 248.595.46001 Boehringer Ingelheim Investigational Site
  • 248.595.46007 Boehringer Ingelheim Investigational Site
  • 248.595.46002 Boehringer Ingelheim Investigational Site
  • 248.595.44003 Boehringer Ingelheim Investigational Site
  • 248.595.44008 Boehringer Ingelheim Investigational Site
  • 248.595.44004 Boehringer Ingelheim Investigational Site
  • 248.595.44002 Boehringer Ingelheim Investigational Site
  • 248.595.44001 Boehringer Ingelheim Investigational Site
  • 248.595.44010 Boehringer Ingelheim Investigational Site
  • 248.595.44011 Boehringer Ingelheim Investigational Site
  • 248.595.44005 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Pramipexole

Delayed Pramipexole

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change From Baseline in the Investigator Rated 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)
Change From Baseline in the Investigator Rated UPDRS Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Total Score at 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)
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at 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.
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at 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).
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Clinically Significant Abnormalities in Vital Signs

Full Information

First Posted
May 3, 2006
Last Updated
May 7, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00321854
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Pramipexole
Arm Type
Experimental
Arm Description
Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Arm Title
Delayed Pramipexole
Arm Type
Experimental
Arm Description
Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Intervention Type
Drug
Intervention Name(s)
pramipexole
Primary Outcome Measure Information:
Title
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Secondary Outcome Measure Information:
Title
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Description
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)
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Description
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)
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Description
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)
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Description
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)
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Description
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)
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Description
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)
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Description
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)
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Description
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)
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Description
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)
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Description
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)
Time Frame
Baseline and Month 3
Title
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
Description
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.
Time Frame
Month 15
Title
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Description
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).
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Description
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Description
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Description
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Description
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Description
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Description
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time Frame
Baseline and Month 9
Title
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Description
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)
Time Frame
Baseline and Month 15
Title
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Description
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)
Time Frame
Baseline and Month 9
Title
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Description
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.
Time Frame
Month 1
Title
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
Description
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.
Time Frame
Month 6
Title
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
Description
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.
Time Frame
Month 9
Title
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
Description
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.
Time Frame
Month 12
Title
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
Description
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.
Time Frame
Month 15
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
Description
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.
Time Frame
Month 1
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
Description
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.
Time Frame
Month 6
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
Description
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.
Time Frame
Month 9
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
Description
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.
Time Frame
Month 12
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
Description
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.
Time Frame
Month 15
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
Description
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.
Time Frame
Month 1
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
Description
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.
Time Frame
Month 6
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
Description
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.
Time Frame
Month 9
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
Description
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.
Time Frame
Month 12
Title
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
Description
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.
Time Frame
Month 15
Title
Percentage Change From Baseline in the Striatum Uptake at Month 15
Description
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).
Time Frame
Baseline and Month 15
Title
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Time Frame
Baseline and Month 15
Title
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Time Frame
Baseline and Month 15
Title
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Time Frame
Baseline and Month 15
Title
Clinically Significant Abnormalities in Vital Signs
Time Frame
Baseline and Month 15

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
23726851
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.595_U09-3780-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.595_Literature.pdf
Description
Related Info

Learn more about this trial

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

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