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Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Primary Purpose

Early Parkinson Disease (Early PD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pramipexol Extended Release

Pramipexol Immediate Release

Placebo

About this trial

This is an interventional treatment trial for Early Parkinson Disease (Early PD)

Eligibility Criteria

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

Inclusion Criteria:

Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinsons disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1) according to the investigators judgement.

Exclusion Criteria:

Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th (DSM-IV)
History of psychosis
Clinically significant electrocardiogram (ECG) abnormalities at screening visit
Clinically significant hypotension
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
Sexually active female of childbearing potential not using a medically approved method of birth control
Serum levels of Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN)
Patients with a creatinine clearance < 50 mL/min
Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
Total cumulative duration of prior exposure to Levodopa of more than 3 months.
Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
Flunarizine within 3 months prior to baseline visit
Known hypersensitivity to Pramipexole or its excipients
Drug abuse (including alcohol), according to Investigators judgement, within 2 years prior to screening.
Participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Pramipexole Extended Release (PPX ER)

Pramipexole Immediate Release (PPX IR)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score

Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.

Secondary Outcome Measures

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale

Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale

Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale

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. Responders are the patients with 'much better' and 'very much better' on the score.

UPDRS II+III Responder Rate (at Least 20% Improvement)

Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.

UPDRS Part I Change From Baseline

UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement

UPDRS Part II Total Score

UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement

UPDRS Part III Total Score

UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement

Beck's Depression Inventory Version I A

The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).

Likert Scale for Pain Related to PD

Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement

Parkinson's Disease Sleep Scale (PDSS)

PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)

Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include: mobility (e.g. fear of falling when walking): 10 items activities of daily living (e.g. difficulty cutting food): 6 items emotional well-being (e.g. feelings of isolation): 6 items stigma (e.g. social embarrassment): 4 items social support: 3 items cognition: 4 items communication: 3 items bodily discomfort: 3 items. A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement.

Change From Baseline in European Quality of Life Visual Analog Scale

European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.

Patients Who Started to Use L-Dopa Rescue Medication

L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population

Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)

mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).

Possible Clinically Significant Abnormal Laboratory Parameters

The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.

Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events

Full Information

NCT ID

NCT00479401

First Posted

May 25, 2007

Last Updated

June 20, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00479401

Brief Title

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Official Title

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

November 2008 (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 objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole. In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

6. Conditions and Keywords

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

Early Parkinson Disease (Early PD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

539 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pramipexole Extended Release (PPX ER)

Arm Type

Experimental

Arm Title

Pramipexole Immediate Release (PPX IR)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pramipexol Extended Release

Intervention Type

Drug

Intervention Name(s)

Pramipexol Immediate Release

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score

Description

Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.

Time Frame

baseline and after 33 weeks treatment

Secondary Outcome Measure Information:

Title

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale

Description

Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale

Time Frame

after 18 weeks of treatment compared to baseline

Title

Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale

Description

Time Frame

after 18 weeks of treatment compared to baseline

Title

UPDRS II+III Responder Rate (at Least 20% Improvement)

Description

Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.

Time Frame

after 33 weeks treatment

Title

UPDRS Part I Change From Baseline

Description

UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement

Time Frame

baseline and after 33 weeks treatment

Title

UPDRS Part II Total Score

Description

UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement

Time Frame

after 33 weeks treatment

Title

UPDRS Part III Total Score

Description

UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement

Time Frame

after 33 weeks treatment

Title

Beck's Depression Inventory Version I A

Description

Time Frame

after 33 weeks treatment

Title

Likert Scale for Pain Related to PD

Description

Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement

Time Frame

after 33 weeks treatment

Title

Parkinson's Disease Sleep Scale (PDSS)

Description

Time Frame

after 33 weeks treatment

Title

Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score

Description

Time Frame

after 33 weeks treatment

Title

Change From Baseline in European Quality of Life Visual Analog Scale

Description

Time Frame

after 33 weeks treatment

Title

Patients Who Started to Use L-Dopa Rescue Medication

Description

L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population

Time Frame

from trial start on to any time before final assessment of the patient, up to 33 weeks

Title

Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)

Description

Time Frame

from trial start on to any time before final assessment of the patient, up to 33 weeks

Title

Possible Clinically Significant Abnormal Laboratory Parameters

Description

The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.

Time Frame

baseline and after 33 weeks of treatment

Title

Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events

Time Frame

baseline and after 33 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. Parkinsons disease diagnosed within 5 years. Patients 30 years of age or older at the time of diagnosis. Modified Hoehn and Yahr stage of 1 to 3. Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1) according to the investigators judgement. Exclusion Criteria: Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy). Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th (DSM-IV) History of psychosis Clinically significant electrocardiogram (ECG) abnormalities at screening visit Clinically significant hypotension 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 Sexually active female of childbearing potential not using a medically approved method of birth control Serum levels of Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN) Patients with a creatinine clearance < 50 mL/min Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit. Total cumulative duration of prior exposure to Levodopa of more than 3 months. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines. Flunarizine within 3 months prior to baseline visit Known hypersensitivity to Pramipexole or its excipients Drug abuse (including alcohol), according to Investigators judgement, within 2 years prior to screening. Participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug

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

248.524.01018 Boehringer Ingelheim Investigational Site

City

Gilbert

State/Province

Arizona

Country

United States

Facility Name

248.524.01004 Boehringer Ingelheim Investigational Site

City

Sun City

State/Province

Arizona

Country

United States

Facility Name

248.524.01016 Boehringer Ingelheim Investigational Site

City

La Jolla

State/Province

California

Country

United States

Facility Name

248.524.01013 Boehringer Ingelheim Investigational Site

City

Oxnard

State/Province

California

Country

United States

Facility Name

248.524.01008 Boehringer Ingelheim Investigational Site

City

Danbury

State/Province

Connecticut

Country

United States

Facility Name

248.524.01010 Boehringer Ingelheim Investigational Site

City

Boca Raton

State/Province

Florida

Country

United States

Facility Name

248.524.01014 Boehringer Ingelheim Investigational Site

City

Augusta

State/Province

Georgia

Country

United States

Facility Name

248.524.01012 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

248.524.01001 Boehringer Ingelheim Investigational Site

City

Kansas City

State/Province

Kansas

Country

United States

Facility Name

248.524.01007 Boehringer Ingelheim Investigational Site

City

Elkridge

State/Province

Maryland

Country

United States

Facility Name

248.524.01015 Boehringer Ingelheim Investigational Site

City

Southfield

State/Province

Michigan

Country

United States

Facility Name

248.524.01017 Boehringer Ingelheim Investigational Site

City

Hattiesburg

State/Province

Mississippi

Country

United States

Facility Name

248.524.01005 Boehringer Ingelheim Investigational Site

City

Commack

State/Province

New York

Country

United States

Facility Name

248.524.01002 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

248.524.01003 Boehringer Ingelheim Investigational Site

City

Midvale

State/Province

Utah

Country

United States

Facility Name

248.524.01009 Boehringer Ingelheim Investigational Site

City

Burlington

State/Province

Vermont

Country

United States

Facility Name

248.524.54001 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

248.524.54002 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

248.524.54003 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

248.524.54007 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

248.524.54008 Instituto de Neurociencias de Buenos Aires

City

Capital Federal

Country

Argentina

Facility Name

248.524.54009 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

248.524.54006 Boehringer Ingelheim Investigational Site

City

Mar del Plata

Country

Argentina

Facility Name

248.524.54004 Boehringer Ingelheim Investigational Site

City

Santa Fe

Country

Argentina

Facility Name

248.524.43001 Boehringer Ingelheim Investigational Site

City

Innsbruck

Country

Austria

Facility Name

248.524.43004 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

248.524.42004 Boehringer Ingelheim Investigational Site

City

Olomouc

Country

Czech Republic

Facility Name

248.524.42003 Boehringer Ingelheim Investigational Site

City

Pardubice

Country

Czech Republic

Facility Name

248.524.42001 Boehringer Ingelheim Investigational Site

City

Praha

Country

Czech Republic

Facility Name

248.524.42002 Boehringer Ingelheim Investigational Site

City

Rychnov nad Kneznou

Country

Czech Republic

Facility Name

248.524.35803 Boehringer Ingelheim Investigational Site

City

Hyvinkää

Country

Finland

Facility Name

248.524.35801 Boehringer Ingelheim Investigational Site

City

Oulu

Country

Finland

Facility Name

248.524.35802 Boehringer Ingelheim Investigational Site

City

Tampere

Country

Finland

Facility Name

248.524.49002 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

248.524.49003 Boehringer Ingelheim Investigational Site

City

Bochum

Country

Germany

Facility Name

248.524.49011 Boehringer Ingelheim Investigational Site

City

Bochum

Country

Germany

Facility Name

248.524.49008 Boehringer Ingelheim Investigational Site

City

Bremerhaven

Country

Germany

Facility Name

248.524.49006 Boehringer Ingelheim Investigational Site

City

Dresden

Country

Germany

Facility Name

248.524.49007 Boehringer Ingelheim Investigational Site

City

Göttingen

Country

Germany

Facility Name

248.524.49001 Boehringer Ingelheim Investigational Site

City

Kassel

Country

Germany

Facility Name

248.524.49004 Boehringer Ingelheim Investigational Site

City

Leipzig

Country

Germany

Facility Name

248.524.49005 Boehringer Ingelheim Investigational Site

City

Marburg

Country

Germany

Facility Name

248.524.36007 Boehringer Ingelheim Investigational Site

City

Eger

Country

Hungary

Facility Name

248.524.36005 Boehringer Ingelheim Investigational Site

City

Györ

Country

Hungary

Facility Name

248.524.36008 Boehringer Ingelheim Investigational Site

City

Miskolc

Country

Hungary

Facility Name

248.524.36004 Boehringer Ingelheim Investigational Site

City

Sopron

Country

Hungary

Facility Name

248.524.36001 Boehringer Ingelheim Investigational Site

City

Szeged

Country

Hungary

Facility Name

248.524.36006 Boehringer Ingelheim Investigational Site

City

Szeged

Country

Hungary

Facility Name

248.524.36003 Boehringer Ingelheim Investigational Site

City

Szombathely

Country

Hungary

Facility Name

248.524.36002 Boehringer Ingelheim Investigational Site

City

Zalaegerszeg

Country

Hungary

Facility Name

248.524.91002 Boehringer Ingelheim Investigational Site

City

Chennai

Country

India

Facility Name

248.524.91009 Boehringer Ingelheim Investigational Site

City

Hyderabad

Country

India

Facility Name

248.524.91010 Boehringer Ingelheim Investigational Site

City

Hyderabad

Country

India

Facility Name

248.524.91001 Boehringer Ingelheim Investigational Site

City

Karnataka

Country

India

Facility Name

248.524.91005 Boehringer Ingelheim Investigational Site

City

Maharashtra

Country

India

Facility Name

248.524.91007 Boehringer Ingelheim Investigational Site

City

Maharashtra

Country

India

Facility Name

248.524.91004 Boehringer Ingelheim Investigational Site

City

New Delhi

Country

India

Facility Name

248.524.91006 Boehringer Ingelheim Investigational Site

City

New Delhi

Country

India

Facility Name

248.524.91011 Boehringer Ingelheim Investigational Site

City

Pune

Country

India

Facility Name

248.524.81010 Boehringer Ingelheim Investigational Site

City

Aomori, Aomori

Country

Japan

Facility Name

248.524.81001 Boehringer Ingelheim Investigational Site

City

Bunkyo-ku, Tokyo

Country

Japan

Facility Name

248.524.81005 Boehringer Ingelheim Investigational Site

City

Fuchu, Tokyo

Country

Japan

Facility Name

248.524.81011 Boehringer Ingelheim Investigational Site

City

Fujisawa, Kanagawa

Country

Japan

Facility Name

248.524.81013 Boehringer Ingelheim Investigational Site

City

Fukuoka, Fukuoka

Country

Japan

Facility Name

248.524.81015 Boehringer Ingelheim Investigational Site

City

Iwamizawa,Hokkaido

Country

Japan

Facility Name

248.524.81003 Boehringer Ingelheim Investigational Site

City

Kodaira, Tokyo

Country

Japan

Facility Name

248.524.81014 Boehringer Ingelheim Investigational Site

City

Kyoto, Kyoto

Country

Japan

Facility Name

248.524.81009 Boehringer Ingelheim Investigational Site

City

Morioka, Iwate

Country

Japan

Facility Name

248.524.81008 Boehringer Ingelheim Investigational Site

City

Okayama, Okayama

Country

Japan

Facility Name

248.524.81006 Boehringer Ingelheim Investigational Site

City

Ota-ku, Tokyo

Country

Japan

Facility Name

248.524.81004 Boehringer Ingelheim Investigational Site

City

Sagamihara, Kanagawa

Country

Japan

Facility Name

248.524.81007 Boehringer Ingelheim Investigational Site

City

Shimogyo-ku, Kyoto, Kyoto

Country

Japan

Facility Name

248.524.81012 Boehringer Ingelheim Investigational Site

City

Shiroishi, Miyagi

Country

Japan

Facility Name

248.524.81002 Boehringer Ingelheim Investigational Site

City

Takamatsu, Kagawa

Country

Japan

Facility Name

248.524.60001 Boehringer Ingelheim Investigational Site

City

Kuala Lumpur

Country

Malaysia

Facility Name

248.524.60004 Boehringer Ingelheim Investigational Site

City

Kuala Terengganu

Country

Malaysia

Facility Name

248.524.60002 Boehringer Ingelheim Investigational Site

City

Pulau Pinang

Country

Malaysia

Facility Name

248.524.07001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.524.07002 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.524.07003 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.524.07004 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

248.524.07005 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

248.524.07006 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

248.524.42103 Boehringer Ingelheim Investigational Site

City

Dubnica nad Vahom

Country

Slovakia

Facility Name

248.524.42101 Boehringer Ingelheim Investigational Site

City

Trnava

Country

Slovakia

Facility Name

248.524.88603 Boehringer Ingelheim Investigational Site

City

Kaohsiung

Country

Taiwan

Facility Name

248.524.88605 Boehringer Ingelheim Investigational Site

City

Taichung

Country

Taiwan

Facility Name

248.524.88601 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

248.524.88602 Boehringer Ingelheim Investigational Site

City

Taoyuan

Country

Taiwan

Facility Name

248.524.38005 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

248.524.38001 Boehringer Ingelheim Investigational Site

City

Lvov

Country

Ukraine

Facility Name

248.524.38002 Boehringer Ingelheim Investigational Site

City

Uzhgorod

Country

Ukraine

Facility Name

248.524.38003 Boehringer Ingelheim Investigational Site

City

Vinnytzya

Country

Ukraine

Facility Name

248.524.38004 Boehringer Ingelheim Investigational Site

City

Zaporizhzhya

Country

Ukraine

Facility Name

248.524.38006 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/248/248.524_U09-1232-03-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.524_Literature.pdf

Description

Related Info

Learn more about this trial

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

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Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Early Parkinson Disease (Early PD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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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