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

NCT ID: NCT00479401

Last Updated: 2014-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

539 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Early Parkinson Disease (Early PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pramipexole Extended Release (PPX ER)

Group Type EXPERIMENTAL

Pramipexol Extended Release

Intervention Type DRUG

Pramipexole Immediate Release (PPX IR)

Group Type EXPERIMENTAL

Pramipexol Immediate Release

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Pramipexol Extended Release

Intervention Type DRUG

Pramipexol Immediate Release

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
2. Parkinsons disease diagnosed within 5 years.
3. Patients 30 years of age or older at the time of diagnosis.
4. Modified Hoehn and Yahr stage of 1 to 3.
5. 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

1. 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).
2. Dementia, as defined by a Mini-Mental State Exam score \< 24 at screening visit
3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th (DSM-IV)
4. History of psychosis
5. Clinically significant electrocardiogram (ECG) abnormalities at screening visit
6. Clinically significant hypotension
7. Malignant melanoma or history of previously treated malignant melanoma
8. 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
9. Pregnancy
10. Sexually active female of childbearing potential not using a medically approved method of birth control
11. Serum levels of Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT), alkaline phosphatases or bilirubin \> 2 Upper Limit of Normal (ULN)
12. Patients with a creatinine clearance \< 50 mL/min
13. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
14. Total cumulative duration of prior exposure to Levodopa of more than 3 months.
15. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
16. Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
17. Flunarizine within 3 months prior to baseline visit
18. Known hypersensitivity to Pramipexole or its excipients
19. Drug abuse (including alcohol), according to Investigators judgement, within 2 years prior to screening.
20. 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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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248.524.01018 Boehringer Ingelheim Investigational Site

Gilbert, Arizona, United States

Site Status

248.524.01004 Boehringer Ingelheim Investigational Site

Sun City, Arizona, United States

Site Status

248.524.01016 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Site Status

248.524.01013 Boehringer Ingelheim Investigational Site

Oxnard, California, United States

Site Status

248.524.01008 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Site Status

248.524.01010 Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Site Status

248.524.01014 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Site Status

248.524.01012 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

248.524.01001 Boehringer Ingelheim Investigational Site

Kansas City, Kansas, United States

Site Status

248.524.01007 Boehringer Ingelheim Investigational Site

Elkridge, Maryland, United States

Site Status

248.524.01015 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

Site Status

248.524.01017 Boehringer Ingelheim Investigational Site

Hattiesburg, Mississippi, United States

Site Status

248.524.01005 Boehringer Ingelheim Investigational Site

Commack, New York, United States

Site Status

248.524.01002 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

248.524.01003 Boehringer Ingelheim Investigational Site

Midvale, Utah, United States

Site Status

248.524.01009 Boehringer Ingelheim Investigational Site

Burlington, Vermont, United States

Site Status

248.524.54001 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

248.524.54002 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

248.524.54003 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

248.524.54007 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

248.524.54008 Instituto de Neurociencias de Buenos Aires

Capital Federal, , Argentina

Site Status

248.524.54009 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

248.524.54006 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

248.524.54004 Boehringer Ingelheim Investigational Site

Santa Fe, , Argentina

Site Status

248.524.43001 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

Site Status

248.524.43004 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

248.524.42004 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

Site Status

248.524.42003 Boehringer Ingelheim Investigational Site

Pardubice, , Czechia

Site Status

248.524.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

248.524.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, , Czechia

Site Status

248.524.35803 Boehringer Ingelheim Investigational Site

Hyvinkää, , Finland

Site Status

248.524.35801 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

248.524.35802 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

248.524.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

248.524.49003 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

248.524.49011 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

248.524.49008 Boehringer Ingelheim Investigational Site

Bremerhaven, , Germany

Site Status

248.524.49006 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

248.524.49007 Boehringer Ingelheim Investigational Site

Göttingen, , Germany

Site Status

248.524.49001 Boehringer Ingelheim Investigational Site

Kassel, , Germany

Site Status

248.524.49004 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

248.524.49005 Boehringer Ingelheim Investigational Site

Marburg, , Germany

Site Status

248.524.36007 Boehringer Ingelheim Investigational Site

Eger, , Hungary

Site Status

248.524.36005 Boehringer Ingelheim Investigational Site

Győr, , Hungary

Site Status

248.524.36008 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

Site Status

248.524.36004 Boehringer Ingelheim Investigational Site

Sopron, , Hungary

Site Status

248.524.36001 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

248.524.36006 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

248.524.36003 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

Site Status

248.524.36002 Boehringer Ingelheim Investigational Site

Zalaegerszeg, , Hungary

Site Status

248.524.91002 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

248.524.91009 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

248.524.91010 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

248.524.91001 Boehringer Ingelheim Investigational Site

Karnataka, , India

Site Status

248.524.91005 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

248.524.91007 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

248.524.91004 Boehringer Ingelheim Investigational Site

New Delhi, , India

Site Status

248.524.91006 Boehringer Ingelheim Investigational Site

New Delhi, , India

Site Status

248.524.91011 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

248.524.81010 Boehringer Ingelheim Investigational Site

Aomori, Aomori, , Japan

Site Status

248.524.81001 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, , Japan

Site Status

248.524.81005 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, , Japan

Site Status

248.524.81011 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, , Japan

Site Status

248.524.81013 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

248.524.81015 Boehringer Ingelheim Investigational Site

Iwamizawa,Hokkaido, , Japan

Site Status

248.524.81003 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, , Japan

Site Status

248.524.81014 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

248.524.81009 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

Site Status

248.524.81008 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

Site Status

248.524.81006 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, , Japan

Site Status

248.524.81004 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, , Japan

Site Status

248.524.81007 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, , Japan

Site Status

248.524.81012 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, , Japan

Site Status

248.524.81002 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, , Japan

Site Status

248.524.60001 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

248.524.60004 Boehringer Ingelheim Investigational Site

Kuala Terengganu, , Malaysia

Site Status

248.524.60002 Boehringer Ingelheim Investigational Site

Pulau Pinang, , Malaysia

Site Status

248.524.07001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.524.07002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.524.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.524.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.524.07005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

248.524.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

248.524.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, , Slovakia

Site Status

248.524.42101 Boehringer Ingelheim Investigational Site

Trnava, , Slovakia

Site Status

248.524.88603 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

248.524.88605 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

248.524.88601 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

248.524.88602 Boehringer Ingelheim Investigational Site

Taoyuan District, , Taiwan

Site Status

248.524.38005 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

248.524.38001 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

248.524.38002 Boehringer Ingelheim Investigational Site

Uzhhorod, , Ukraine

Site Status

248.524.38003 Boehringer Ingelheim Investigational Site

Vinnytzya, , Ukraine

Site Status

248.524.38004 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

248.524.38006 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Argentina Austria Czechia Finland Germany Hungary India Japan Malaysia Russia Slovakia Taiwan Ukraine

Related Links

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

Related Info

Other Identifiers

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Eudract No 2007-000073-39

Identifier Type: -

Identifier Source: secondary_id

248.524

Identifier Type: -

Identifier Source: org_study_id

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