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Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pramipexole

Placebo

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

32 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Completion of the double-blind trial 248.525
Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion criteria:

Patients prematurely withdrawn from the double-blind trial 248.525
Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (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
History of psychosis, except history of drug induced hallucinations
History of deep brain stimulation
Clinically significant ECG abnormalities at baseline
Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
Malignant melanoma or history of previously treated malignant melanoma
Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
Pregnancy or breast-feeding
Sexually active female of childbearing potential not using a medically approved method of birth control
Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin > 2 upper limit normal (ULN) at baseline
Patients with a creatinine clearance < 50 mL/min at baseline
Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
Flunarizine within 3 months prior to baseline
Known hypersensitivity to pramipexole or its excipients
Drug abuse, according to investigators judgement, within 2 years prior to baseline
Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pramipexole

Placebo

Arm Description

Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily

Patients 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 advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.

Secondary Outcome Measures

Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 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

UPDRS II+III Change From Open Label (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

Number of Participants With UPDRS II+III Response

A response means an improvement of >=20% in UPDRS II+III 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

Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).

Percentage Off Time During Waking Hours Total Score: Change From Baseline

Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement

Number of Participants With Response in Percentage Off Time During Waking Hours

Response means >=20% improvement relative to OL baseline in the % off-time during waking hours

Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.

Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

Number of Participants With Response in CGI-I

Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (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 PPX ER or IR, all patients with no change to very much improved were considered as responders

Number of Participants With Response in PGI-I

Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (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 PPX ER or IR, all patients with no change to very much better were considered as responders

Number of Participants With Response in PGI-I for Early Morning Off Symptoms

Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (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 PPX ER or IR, all patients with no change to very much better were considered as responders

UPDRS I Total Score and Change From OL Baseline at Week 80

UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood

UPDRS II Total Score and Change From OL Baseline at Week 80

UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities

UPDRS III Total Score and Change From OL Baseline at Week 80

UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms

UPDRS IV Total Score and Change From OL Baseline at Week 80

UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy

Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80

PFS-16 (Parkinson fatigue scale) 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 Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80

Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline

Number of Participants With Serious Adverse Events

Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set

Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set

Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set

ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)

Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set

The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.

Full Information

NCT ID

NCT00577460

First Posted

December 19, 2007

Last Updated

May 7, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00577460

Brief Title

Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

December 2007 (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 extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 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

391 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pramipexole

Arm Type

Active Comparator

Arm Description

Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Intervention Description

Pramipexole ER 0.375 -4.5 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets identical to Pramipexole ER tablets

Primary Outcome Measure Information:

Title

Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

Description

Time Frame

80 weeks

Secondary Outcome Measure Information:

Title

Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

Description

Time Frame

One week

Title

UPDRS II+III Change From Open Label (OL) 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

OL Baseline and week 80

Title

Number of Participants With UPDRS II+III Response

Description

Time Frame

Week 80

Title

Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

Description

Time Frame

One week

Title

Percentage Off Time During Waking Hours Total Score: Change From Baseline

Description

Time Frame

Baseline and week 80

Title

Number of Participants With Response in Percentage Off Time During Waking Hours

Description

Response means >=20% improvement relative to OL baseline in the % off-time during waking hours

Time Frame

80 weeks

Title

Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Description

Time Frame

Baseline and week 80

Title

Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Description

Time Frame

Baseline and week 80

Title

Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Description

Time Frame

Baseline and week 80

Title

Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Description

Time Frame

Baseline and week 80

Title

Number of Participants With Response in CGI-I

Description

Time Frame

32 weeks

Title

Number of Participants With Response in PGI-I

Description

Time Frame

32 weeks

Title

Number of Participants With Response in PGI-I for Early Morning Off Symptoms

Description

Time Frame

32 weeks

Title

UPDRS I Total Score and Change From OL Baseline at Week 80

Description

UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood

Time Frame

OL baseline and week 80

Title

UPDRS II Total Score and Change From OL Baseline at Week 80

Description

UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities

Time Frame

OL baseline and week 80

Title

UPDRS III Total Score and Change From OL Baseline at Week 80

Description

UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms

Time Frame

OL baseline and week 80

Title

UPDRS IV Total Score and Change From OL Baseline at Week 80

Description

UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy

Time Frame

OL baseline and week 80

Title

Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80

Description

PFS-16 (Parkinson fatigue scale) 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

Title

Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80

Time Frame

OL baseline and week 80

Title

Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline

Time Frame

OL baseline and week 80

Title

Number of Participants With Serious Adverse Events

Time Frame

80 weeks

Title

Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set

Time Frame

OL Baseline and Week 80

Title

Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set

Description

ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)

Time Frame

OL Baseline and Week 80

Title

Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set

Description

Time Frame

Baseline, 80 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

32 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Completion of the double-blind trial 248.525 Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation). Exclusion criteria: Patients prematurely withdrawn from the double-blind trial 248.525 Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (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 History of psychosis, except history of drug induced hallucinations History of deep brain stimulation Clinically significant ECG abnormalities at baseline Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline Malignant melanoma or history of previously treated malignant melanoma Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study Pregnancy or breast-feeding Sexually active female of childbearing potential not using a medically approved method of birth control Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin > 2 upper limit normal (ULN) at baseline Patients with a creatinine clearance < 50 mL/min at baseline Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines Flunarizine within 3 months prior to baseline Known hypersensitivity to pramipexole or its excipients Drug abuse, according to investigators judgement, within 2 years prior to baseline Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) 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

248.634.43005 Boehringer Ingelheim Investigational Site

City

Linz

Country

Austria

Facility Name

248.634.42003 Boehringer Ingelheim Investigational Site

City

Pardubice

Country

Czech Republic

Facility Name

248.634.42001 Boehringer Ingelheim Investigational Site

City

Praha

Country

Czech Republic

Facility Name

248.634.42005 Boehringer Ingelheim Investigational Site

City

Rakovnik

Country

Czech Republic

Facility Name

248.634.42002 Boehringer Ingelheim Investigational Site

City

Rychnov nad Kneznou

Country

Czech Republic

Facility Name

248.634.42004 Boehringer Ingelheim Investigational Site

City

Valasske Mezirici

Country

Czech Republic

Facility Name

248.634.36005 Boehringer Ingelheim Investigational Site

City

Györ

Country

Hungary

Facility Name

248.634.36003 Boehringer Ingelheim Investigational Site

City

Kecskemét

Country

Hungary

Facility Name

248.634.36006 Boehringer Ingelheim Investigational Site

City

Szeged

Country

Hungary

Facility Name

248.634.36004 Boehringer Ingelheim Investigational Site

City

Veszprem

Country

Hungary

Facility Name

248.634.91002 Boehringer Ingelheim Investigational Site

City

Chennai

Country

India

Facility Name

248.634.91001 Boehringer Ingelheim Investigational Site

City

Delhi

Country

India

Facility Name

248.634.91003 Boehringer Ingelheim Investigational Site

City

Hyderabad

Country

India

Facility Name

248.634.91007 Boehringer Ingelheim Investigational Site

City

Indore

Country

India

Facility Name

248.634.91005 Boehringer Ingelheim Investigational Site

City

Karnataka

Country

India

Facility Name

248.634.91006 Boehringer Ingelheim Investigational Site

City

Pune

Country

India

Facility Name

248.634.39001 Boehringer Ingelheim Investigational Site

City

Catania

Country

Italy

Facility Name

248.634.39010 Boehringer Ingelheim Investigational Site

City

Catanzaro

Country

Italy

Facility Name

248.634.39009 Boehringer Ingelheim Investigational Site

City

Chieti

Country

Italy

Facility Name

248.634.39007 Boehringer Ingelheim Investigational Site

City

Grosseto

Country

Italy

Facility Name

248.634.39002 Boehringer Ingelheim Investigational Site

City

Napolii

Country

Italy

Facility Name

248.634.39008 Boehringer Ingelheim Investigational Site

City

Pisa

Country

Italy

Facility Name

248.634.39005 Boehringer Ingelheim Investigational Site

City

Roma

Country

Italy

Facility Name

248.634.39011 Boehringer Ingelheim Investigational Site

City

Roma

Country

Italy

Facility Name

248.634.82001 Boehringer Ingelheim Investigational Site

City

Gyeonggi-do

Country

Korea, Republic of

Facility Name

248.634.82008 Boehringer Ingelheim Investigational Site

City

Kyeonggi-do

Country

Korea, Republic of

Facility Name

248.634.82007 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

248.634.82002 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

248.634.82003 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

248.634.82004 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

248.634.82005 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

248.634.82006 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

248.634.63202 Boehringer Ingelheim Investigational Site

City

Cruz, Manila

Country

Philippines

Facility Name

248.634.63207 Boehringer Ingelheim Investigational Site

City

Ermita, Manila

Country

Philippines

Facility Name

248.634.63210 Boehringer Ingelheim Investigational Site

City

Makati City

Country

Philippines

Facility Name

248.634.63205 Boehringer Ingelheim Investigational Site

City

Manila

Country

Philippines

Facility Name

248.634.63206 Boehringer Ingelheim Investigational Site

City

Manila

Country

Philippines

Facility Name

248.634.63201 Boehringer Ingelheim Investigational Site

City

Pasig City

Country

Philippines

Facility Name

248.634.63204 Boehringer Ingelheim Investigational Site

City

Quezon City

Country

Philippines

Facility Name

248.634.63208 Boehringer Ingelheim Investigational Site

City

Quezon

Country

Philippines

Facility Name

248.634.48001 Boehringer Ingelheim Investigational Site

City

Gdansk

Country

Poland

Facility Name

248.634.48003 Boehringer Ingelheim Investigational Site

City

Krakow

Country

Poland

Facility Name

248.634.48002 Boehringer Ingelheim Investigational Site

City

Warsaw

Country

Poland

Facility Name

248.634.07001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.634.07002 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.634.07003 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.634.07004 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.634.07007 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.634.07006 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

248.634.42104 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

248.634.42105 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

248.634.42103 Boehringer Ingelheim Investigational Site

City

Dubnica nad Vahom

Country

Slovakia

Facility Name

248.634.42101 Boehringer Ingelheim Investigational Site

City

Trnava

Country

Slovakia

Facility Name

248.634.34001 Boehringer Ingelheim Investigational Site

City

Alcorcon (Madrid)

Country

Spain

Facility Name

248.634.34003 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

248.634.34004 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

248.634.34005 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

248.634.34002 Boehringer Ingelheim Investigational Site

City

San Cugat del Valles (Barcelona)

Country

Spain

Facility Name

248.634.34008 Boehringer Ingelheim Investigational Site

City

Tarrasa (Barcelona)

Country

Spain

Facility Name

248.634.46005 Boehringer Ingelheim Investigational Site

City

Malmö

Country

Sweden

Facility Name

248.634.46002 Boehringer Ingelheim Investigational Site

City

Nyköping

Country

Sweden

Facility Name

248.634.46001 Boehringer Ingelheim Investigational Site

City

Stockholm

Country

Sweden

Facility Name

248.634.38003 Boehringer Ingelheim Investigational Site

City

Dnipropetrovsk

Country

Ukraine

Facility Name

248.634.38006 Boehringer Ingelheim Investigational Site

City

Kharkiv

Country

Ukraine

Facility Name

248.634.38002 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

248.634.38004 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

248.634.38005 Boehringer Ingelheim Investigational Site

City

Zaporizhzhya

Country

Ukraine

Facility Name

248.634.38001 Boehringer Ingelheim Investigational Site

City

Zaporozhye

Country

Ukraine

Facility Name

248.634.44007 Boehringer Ingelheim Investigational Site

City

Blackburn

Country

United Kingdom

Facility Name

248.634.44003 Boehringer Ingelheim Investigational Site

City

Salford

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.634_U11-1427-01-DS.pdf

Description

Related Info

Learn more about this trial

Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

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Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

Parkinson Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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