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Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Completion of the double-blind trial 248.524 or 248.636
  2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
  3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation).

Exclusion criteria:

  1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
  2. Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
  3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.History of psychosis, except history of drug induced hallucinations.

5. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding.

10. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin > 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance < 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.

14. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.Any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline.

17. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.

19. Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.

Sites / Locations

  • 248.633.01004 Boehringer Ingelheim Investigational Site
  • 248.633.01018 Boehringer Ingelheim Investigational Site
  • 248.633.01016 Boehringer Ingelheim Investigational Site
  • 248.633.01013 Boehringer Ingelheim Investigational Site
  • 248.633.01008 Boehringer Ingelheim Investigational Site
  • 248.633.01010 Boehringer Ingelheim Investigational Site
  • 248.633.01012 Boehringer Ingelheim Investigational Site
  • 248.633.01001 Boehringer Ingelheim Investigational Site
  • 248.633.01005 Boehringer Ingelheim Investigational Site
  • 248.633.01009 Boehringer Ingelheim Investigational Site
  • 248.633.43001 Boehringer Ingelheim Investigational Site
  • 248.633.43004 Boehringer Ingelheim Investigational Site
  • 248.633.42004 Boehringer Ingelheim Investigational Site
  • 248.633.42003 Boehringer Ingelheim Investigational Site
  • 248.633.42001 Boehringer Ingelheim Investigational Site
  • 248.633.42002 Boehringer Ingelheim Investigational Site
  • 248.633.35803 Boehringer Ingelheim Investigational Site
  • 248.633.35801 Boehringer Ingelheim Investigational Site
  • 248.633.35802 Boehringer Ingelheim Investigational Site
  • 248.633.3303A Boehringer Ingelheim Investigational Site
  • 248.633.3303B Boehringer Ingelheim Investigational Site
  • 248.633.3303C Boehringer Ingelheim Investigational Site
  • 248.633.3309A Boehringer Ingelheim Investigational Site
  • 248.633.3309B Boehringer Ingelheim Investigational Site
  • 248.633.3305A Boehringer Ingelheim Investigational Site
  • 248.633.3305B Boehringer Ingelheim Investigational Site
  • 248.633.3313A Boehringer Ingelheim Investigational Site
  • 248.633.3304A Boehringer Ingelheim Investigational Site
  • 248.633.3308A Boehringer Ingelheim Investigational Site
  • 248.633.3308B Boehringer Ingelheim Investigational Site
  • 248.633.3308C Boehringer Ingelheim Investigational Site
  • 248.633.3308D Boehringer Ingelheim Investigational Site
  • 248.633.3308E Boehringer Ingelheim Investigational Site
  • 248.633.3302A Boehringer Ingelheim Investigational Site
  • 248.633.3302B Boehringer Ingelheim Investigational Site
  • 248.633.3302C Boehringer Ingelheim Investigational Site
  • 248.633.3306A Boehringer Ingelheim Investigational Site
  • 248.633.3306B Boehringer Ingelheim Investigational Site
  • 248.633.3306C Boehringer Ingelheim Investigational Site
  • 248.633.3306D Boehringer Ingelheim Investigational Site
  • 248.633.3306F Boehringer Ingelheim Investigational Site
  • 248.633.3312A Boehringer Ingelheim Investigational Site
  • 248.633.3312B Boehringer Ingelheim Investigational Site
  • 248.633.3311A Boehringer Ingelheim Investigational Site
  • 248.633.3311B Boehringer Ingelheim Investigational Site
  • 248.633.3301C Boehringer Ingelheim Investigational Site
  • 248.633.3301B Boehringer Ingelheim Investigational Site
  • 248.633.3301A Boehringer Ingelheim Investigational Site
  • 248.633.3301D Boehringer Ingelheim Investigational Site
  • 248.633.3301F Boehringer Ingelheim Investigational Site
  • 248.633.3301G Boehringer Ingelheim Investigational Site
  • 248.633.49009 Boehringer Ingelheim Investigational Site
  • 248.633.49003 Boehringer Ingelheim Investigational Site
  • 248.633.49002 Boehringer Ingelheim Investigational Site
  • 248.633.49004 Boehringer Ingelheim Investigational Site
  • 248.633.49018 Boehringer Ingelheim Investigational Site
  • 248.633.49019 Boehringer Ingelheim Investigational Site
  • 248.633.49005 Boehringer Ingelheim Investigational Site
  • 248.633.49016 Boehringer Ingelheim Investigational Site
  • 248.633.49007 Boehringer Ingelheim Investigational Site
  • 248.633.49011 Boehringer Ingelheim Investigational Site
  • 248.633.49017 Boehringer Ingelheim Investigational Site
  • 248.633.49001 Boehringer Ingelheim Investigational Site
  • 248.633.49012 Boehringer Ingelheim Investigational Site
  • 248.633.49013 Boehringer Ingelheim Investigational Site
  • 248.633.49015 Boehringer Ingelheim Investigational Site
  • 248.633.36007 Boehringer Ingelheim Investigational Site
  • 248.633.36005 Boehringer Ingelheim Investigational Site
  • 248.633.36008 Boehringer Ingelheim Investigational Site
  • 248.633.36004 Boehringer Ingelheim Investigational Site
  • 248.633.36001 Boehringer Ingelheim Investigational Site
  • 248.633.36006 Boehringer Ingelheim Investigational Site
  • 248.633.36003 Boehringer Ingelheim Investigational Site
  • 248.633.36002 Boehringer Ingelheim Investigational Site
  • 248.633.91002 Boehringer Ingelheim Investigational Site
  • 248.633.91009 Boehringer Ingelheim Investigational Site
  • 248.633.91001 Boehringer Ingelheim Investigational Site
  • 248.633.91005 Boehringer Ingelheim Investigational Site
  • 248.633.91007 Boehringer Ingelheim Investigational Site
  • 248.633.91004 Boehringer Ingelheim Investigational Site
  • 248.633.91011 Boehringer Ingelheim Investigational Site
  • 248.633.81010 Boehringer Ingelheim Investigational Site
  • 248.633.81001 Boehringer Ingelheim Investigational Site
  • 248.633.81005 Boehringer Ingelheim Investigational Site
  • 248.633.81011 Boehringer Ingelheim Investigational Site
  • 248.633.81013 Boehringer Ingelheim Investigational Site
  • 248.633.81015 Boehringer Ingelheim Investigational Site
  • 248.633.81003 Boehringer Ingelheim Investigational Site
  • 248.633.81014 Boehringer Ingelheim Investigational Site
  • 248.633.81009 Boehringer Ingelheim Investigational Site
  • 248.633.81008 Boehringer Ingelheim Investigational Site
  • 248.633.81006 Boehringer Ingelheim Investigational Site
  • 248.633.81004 Boehringer Ingelheim Investigational Site
  • 248.633.81007 Boehringer Ingelheim Investigational Site
  • 248.633.81012 Boehringer Ingelheim Investigational Site
  • 248.633.81002 Boehringer Ingelheim Investigational Site
  • 248.633.60004 Boehringer Ingelheim Investigational Site
  • 248.633.31002 Boehringer Ingelheim Investigational Site
  • 248.633.31003 Boehringer Ingelheim Investigational Site
  • 248.633.31006 Boehringer Ingelheim Investigational Site
  • 248.633.31004 Boehringer Ingelheim Investigational Site
  • 248.633.31001 Boehringer Ingelheim Investigational Site
  • 248.633.07001 Boehringer Ingelheim Investigational Site
  • 248.633.07002 Boehringer Ingelheim Investigational Site
  • 248.633.07003 Boehringer Ingelheim Investigational Site
  • 248.633.07004 Boehringer Ingelheim Investigational Site
  • 248.633.07006 Boehringer Ingelheim Investigational Site
  • 248.633.42103 Boehringer Ingelheim Investigational Site
  • 248.633.42101 Boehringer Ingelheim Investigational Site
  • 248.633.88603 Boehringer Ingelheim Investigational Site
  • 248.633.88605 Boehringer Ingelheim Investigational Site
  • 248.633.88601 Boehringer Ingelheim Investigational Site
  • 248.633.88602 Boehringer Ingelheim Investigational Site
  • 248.633.38005 Boehringer Ingelheim Investigational Site
  • 248.633.38001 Boehringer Ingelheim Investigational Site
  • 248.633.38002 Boehringer Ingelheim Investigational Site
  • 248.633.38003 Boehringer Ingelheim Investigational Site
  • 248.633.38004 Boehringer Ingelheim Investigational Site
  • 248.633.38006 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pramipexole

Placebo

Arm Description

Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily

Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.

Outcomes

Primary Outcome Measures

Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)
A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
UPDRS I Total Score: Change From OL Baseline
UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood
UPDRS II Total Score: Change From OL Baseline
UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.
UPDRS III Total Score: Change From OL Baseline
UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms
Response in Clinical Global Impression of Improvement (CGI-I)
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders
Response in Patient Global Impression of Improvement (PGI-I)
Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.
Number of Patients Introducing L-Dopa Medication in OL Trial
Number of patients requiring Levodopa supplementation during the study
L-Dopa Dose: Change From OL Baseline
Change from open-label baseline in Levodopa dose
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment
Patient Preference Regarding Treatment Dosing
Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing
Patient Rating of Convenience of Treatment Dosing
Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing

Full Information

First Posted
January 15, 2008
Last Updated
June 3, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00601523
Brief Title
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Official Title
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (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
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pramipexole
Arm Type
Active Comparator
Arm Description
Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
Intervention Type
Drug
Intervention Name(s)
Pramipexole
Intervention Description
ER 0.375-4,5 mg
Primary Outcome Measure Information:
Title
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Description
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
Time Frame
80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
Description
UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Time Frame
Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)
Description
A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Time Frame
OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
UPDRS I Total Score: Change From OL Baseline
Description
UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood
Time Frame
OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
UPDRS II Total Score: Change From OL Baseline
Description
UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.
Time Frame
OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
UPDRS III Total Score: Change From OL Baseline
Description
UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms
Time Frame
OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
Response in Clinical Global Impression of Improvement (CGI-I)
Description
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders
Time Frame
OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Title
Response in Patient Global Impression of Improvement (PGI-I)
Description
Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders
Time Frame
OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Title
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
Description
PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.
Time Frame
OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
Number of Patients Introducing L-Dopa Medication in OL Trial
Description
Number of patients requiring Levodopa supplementation during the study
Time Frame
80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Title
L-Dopa Dose: Change From OL Baseline
Description
Change from open-label baseline in Levodopa dose
Time Frame
OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Title
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
Description
Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment
Time Frame
Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)
Title
Patient Preference Regarding Treatment Dosing
Description
Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing
Time Frame
80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Title
Patient Rating of Convenience of Treatment Dosing
Description
Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing
Time Frame
80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Completion of the double-blind trial 248.524 or 248.636 Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation). Exclusion criteria: Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636. Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.History of psychosis, except history of drug induced hallucinations. 5. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding. 10. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin > 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance < 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline. 14. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.Any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline. 17. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline. 19. Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.
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
248.633.01004 Boehringer Ingelheim Investigational Site
City
Sun City
State/Province
Arizona
Country
United States
Facility Name
248.633.01018 Boehringer Ingelheim Investigational Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
248.633.01016 Boehringer Ingelheim Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
248.633.01013 Boehringer Ingelheim Investigational Site
City
Oxnard
State/Province
California
Country
United States
Facility Name
248.633.01008 Boehringer Ingelheim Investigational Site
City
Danbury
State/Province
Connecticut
Country
United States
Facility Name
248.633.01010 Boehringer Ingelheim Investigational Site
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
248.633.01012 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
248.633.01001 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
248.633.01005 Boehringer Ingelheim Investigational Site
City
Commack
State/Province
New York
Country
United States
Facility Name
248.633.01009 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
248.633.43001 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
248.633.43004 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
248.633.42004 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
248.633.42003 Boehringer Ingelheim Investigational Site
City
Pardubice
Country
Czech Republic
Facility Name
248.633.42001 Boehringer Ingelheim Investigational Site
City
Praha
Country
Czech Republic
Facility Name
248.633.42002 Boehringer Ingelheim Investigational Site
City
Rychnov nad Kneznou
Country
Czech Republic
Facility Name
248.633.35803 Boehringer Ingelheim Investigational Site
City
Hyvinkää
Country
Finland
Facility Name
248.633.35801 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
248.633.35802 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
248.633.3303A Boehringer Ingelheim Investigational Site
City
Aix en Provence
Country
France
Facility Name
248.633.3303B Boehringer Ingelheim Investigational Site
City
Aix en Provence
Country
France
Facility Name
248.633.3303C Boehringer Ingelheim Investigational Site
City
Aix en Provence
Country
France
Facility Name
248.633.3309A Boehringer Ingelheim Investigational Site
City
Clermont Ferrand
Country
France
Facility Name
248.633.3309B Boehringer Ingelheim Investigational Site
City
Clermont Ferrand
Country
France
Facility Name
248.633.3305A Boehringer Ingelheim Investigational Site
City
Créteil
Country
France
Facility Name
248.633.3305B Boehringer Ingelheim Investigational Site
City
Créteil
Country
France
Facility Name
248.633.3313A Boehringer Ingelheim Investigational Site
City
Dijon cedex
Country
France
Facility Name
248.633.3304A Boehringer Ingelheim Investigational Site
City
Evreux
Country
France
Facility Name
248.633.3308A Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
248.633.3308B Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
248.633.3308C Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
248.633.3308D Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
248.633.3308E Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
248.633.3302A Boehringer Ingelheim Investigational Site
City
Marseille cedex 5
Country
France
Facility Name
248.633.3302B Boehringer Ingelheim Investigational Site
City
Marseille cedex 5
Country
France
Facility Name
248.633.3302C Boehringer Ingelheim Investigational Site
City
Marseille cedex 5
Country
France
Facility Name
248.633.3306A Boehringer Ingelheim Investigational Site
City
Montpellier cédex 5
Country
France
Facility Name
248.633.3306B Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
248.633.3306C Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
248.633.3306D Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
248.633.3306F Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
248.633.3312A Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
248.633.3312B Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
248.633.3311A Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
248.633.3311B Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
248.633.3301C Boehringer Ingelheim Investigational Site
City
Toulouse Cedex 7
Country
France
Facility Name
248.633.3301B Boehringer Ingelheim Investigational Site
City
Toulouse cedex
Country
France
Facility Name
248.633.3301A Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
248.633.3301D Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
248.633.3301F Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
248.633.3301G Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
248.633.49009 Boehringer Ingelheim Investigational Site
City
Achim bei Bremen
Country
Germany
Facility Name
248.633.49003 Boehringer Ingelheim Investigational Site
City
Berlin-Steglitz
Country
Germany
Facility Name
248.633.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.633.49004 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.633.49018 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.633.49019 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
248.633.49005 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
248.633.49016 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
248.633.49007 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
248.633.49011 Boehringer Ingelheim Investigational Site
City
Gera
Country
Germany
Facility Name
248.633.49017 Boehringer Ingelheim Investigational Site
City
Karlsruhe
Country
Germany
Facility Name
248.633.49001 Boehringer Ingelheim Investigational Site
City
Kassel
Country
Germany
Facility Name
248.633.49012 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
248.633.49013 Boehringer Ingelheim Investigational Site
City
Marburg
Country
Germany
Facility Name
248.633.49015 Boehringer Ingelheim Investigational Site
City
Unterhaching
Country
Germany
Facility Name
248.633.36007 Boehringer Ingelheim Investigational Site
City
Eger
Country
Hungary
Facility Name
248.633.36005 Boehringer Ingelheim Investigational Site
City
Györ
Country
Hungary
Facility Name
248.633.36008 Boehringer Ingelheim Investigational Site
City
Miskolc
Country
Hungary
Facility Name
248.633.36004 Boehringer Ingelheim Investigational Site
City
Sopron
Country
Hungary
Facility Name
248.633.36001 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
248.633.36006 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
248.633.36003 Boehringer Ingelheim Investigational Site
City
Szombathely
Country
Hungary
Facility Name
248.633.36002 Boehringer Ingelheim Investigational Site
City
Zalaegerszeg
Country
Hungary
Facility Name
248.633.91002 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
248.633.91009 Boehringer Ingelheim Investigational Site
City
Hyderabad
Country
India
Facility Name
248.633.91001 Boehringer Ingelheim Investigational Site
City
Karnataka
Country
India
Facility Name
248.633.91005 Boehringer Ingelheim Investigational Site
City
Maharashtra
Country
India
Facility Name
248.633.91007 Boehringer Ingelheim Investigational Site
City
Maharashtra
Country
India
Facility Name
248.633.91004 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
248.633.91011 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
248.633.81010 Boehringer Ingelheim Investigational Site
City
Aomori, Aomori
Country
Japan
Facility Name
248.633.81001 Boehringer Ingelheim Investigational Site
City
Bunkyo-ku, Tokyo
Country
Japan
Facility Name
248.633.81005 Boehringer Ingelheim Investigational Site
City
Fuchu, Tokyo
Country
Japan
Facility Name
248.633.81011 Boehringer Ingelheim Investigational Site
City
Fujisawa, Kanagawa
Country
Japan
Facility Name
248.633.81013 Boehringer Ingelheim Investigational Site
City
Fukuoka, Fukuoka
Country
Japan
Facility Name
248.633.81015 Boehringer Ingelheim Investigational Site
City
Iwamizawa,Hokkaido
Country
Japan
Facility Name
248.633.81003 Boehringer Ingelheim Investigational Site
City
Kodaira, Tokyo
Country
Japan
Facility Name
248.633.81014 Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
Country
Japan
Facility Name
248.633.81009 Boehringer Ingelheim Investigational Site
City
Morioka, Iwate
Country
Japan
Facility Name
248.633.81008 Boehringer Ingelheim Investigational Site
City
Okayama, Okayama
Country
Japan
Facility Name
248.633.81006 Boehringer Ingelheim Investigational Site
City
Ota-ku, Tokyo
Country
Japan
Facility Name
248.633.81004 Boehringer Ingelheim Investigational Site
City
Sagamihara, Kanagawa
Country
Japan
Facility Name
248.633.81007 Boehringer Ingelheim Investigational Site
City
Shimogyo-ku, Kyoto, Kyoto
Country
Japan
Facility Name
248.633.81012 Boehringer Ingelheim Investigational Site
City
Shiroishi, Miyagi
Country
Japan
Facility Name
248.633.81002 Boehringer Ingelheim Investigational Site
City
Takamatsu, Kagawa
Country
Japan
Facility Name
248.633.60004 Boehringer Ingelheim Investigational Site
City
Kuala Terengganu
Country
Malaysia
Facility Name
248.633.31002 Boehringer Ingelheim Investigational Site
City
Geldrop
Country
Netherlands
Facility Name
248.633.31003 Boehringer Ingelheim Investigational Site
City
Helmond
Country
Netherlands
Facility Name
248.633.31006 Boehringer Ingelheim Investigational Site
City
Maastricht
Country
Netherlands
Facility Name
248.633.31004 Boehringer Ingelheim Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
248.633.31001 Boehringer Ingelheim Investigational Site
City
Sittard-geleen
Country
Netherlands
Facility Name
248.633.07001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.633.07002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.633.07003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.633.07004 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
248.633.07006 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
248.633.42103 Boehringer Ingelheim Investigational Site
City
Dubnica nad Vahom
Country
Slovakia
Facility Name
248.633.42101 Boehringer Ingelheim Investigational Site
City
Trnava
Country
Slovakia
Facility Name
248.633.88603 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
248.633.88605 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
248.633.88601 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
248.633.88602 Boehringer Ingelheim Investigational Site
City
Taoyuan
Country
Taiwan
Facility Name
248.633.38005 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
248.633.38001 Boehringer Ingelheim Investigational Site
City
Lvov
Country
Ukraine
Facility Name
248.633.38002 Boehringer Ingelheim Investigational Site
City
Uzhgorod
Country
Ukraine
Facility Name
248.633.38003 Boehringer Ingelheim Investigational Site
City
Vinnytzya
Country
Ukraine
Facility Name
248.633.38004 Boehringer Ingelheim Investigational Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
248.633.38006 Boehringer Ingelheim Investigational Site
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.633_U11-1118.pdf
Description
Related Info

Learn more about this trial

Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

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