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

NCT00479401 | Completed Phase 3 Results

• 2 other identifiers: 248.524Eudract No 2007-000073-39
• Study Type: interventional
• Target: 539
• Locations: 14 countries
• Sites: 95

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

Conditions

Early Parkinson Disease (Early PD)

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and after 33 weeks treatment

Secondary Outcomes (15)

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

  after 18 weeks of treatment compared to baseline

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

  after 18 weeks of treatment compared to baseline

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

  after 33 weeks treatment

• UPDRS Part I Change From Baseline

  baseline and after 33 weeks treatment

• UPDRS Part II Total Score

  after 33 weeks treatment

Study Arms (3)

Pramipexole Extended Release (PPX ER)

EXPERIMENTAL

Drug: Pramipexol Extended Release

Pramipexole Immediate Release (PPX IR)

EXPERIMENTAL

Drug: Pramipexol Immediate Release

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pramipexol Extended Release DRUG

Pramipexole Extended Release (PPX ER)

Pramipexol Immediate Release DRUG

Pramipexole Immediate Release (PPX IR)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (95)

248.524.01018 Boehringer Ingelheim Investigational Site

Gilbert, Arizona, United States

Location

248.524.01004 Boehringer Ingelheim Investigational Site

Sun City, Arizona, United States

Location

248.524.01016 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

248.524.01013 Boehringer Ingelheim Investigational Site

Oxnard, California, United States

Location

248.524.01008 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Location

248.524.01010 Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Location

248.524.01014 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

248.524.01012 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.524.01001 Boehringer Ingelheim Investigational Site

Kansas City, Kansas, United States

Location

248.524.01007 Boehringer Ingelheim Investigational Site

Elkridge, Maryland, United States

Location

248.524.01015 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

Location

248.524.01017 Boehringer Ingelheim Investigational Site

Hattiesburg, Mississippi, United States

Location

248.524.01005 Boehringer Ingelheim Investigational Site

Commack, New York, United States

Location

248.524.01002 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

248.524.01003 Boehringer Ingelheim Investigational Site

Midvale, Utah, United States

Location

248.524.01009 Boehringer Ingelheim Investigational Site

Burlington, Vermont, United States

Location

248.524.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

248.524.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

248.524.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

248.524.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

248.524.54008 Instituto de Neurociencias de Buenos Aires

Capital Federal, Argentina

Location

248.524.54009 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

248.524.54006 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

248.524.54004 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

Location

248.524.43001 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

248.524.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

248.524.42004 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

248.524.42003 Boehringer Ingelheim Investigational Site

Pardubice, Czechia

Location

248.524.42001 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

248.524.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, Czechia

Location

248.524.35803 Boehringer Ingelheim Investigational Site

Hyvinkää, Finland

Location

248.524.35801 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.524.35802 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

248.524.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.524.49003 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

248.524.49011 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

248.524.49008 Boehringer Ingelheim Investigational Site

Bremerhaven, Germany

Location

248.524.49006 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

248.524.49007 Boehringer Ingelheim Investigational Site

Göttingen, Germany

Location

248.524.49001 Boehringer Ingelheim Investigational Site

Kassel, Germany

Location

248.524.49004 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

248.524.49005 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

248.524.36007 Boehringer Ingelheim Investigational Site

Eger, Hungary

Location

248.524.36005 Boehringer Ingelheim Investigational Site

Győr, Hungary

Location

248.524.36008 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

248.524.36004 Boehringer Ingelheim Investigational Site

Sopron, Hungary

Location

248.524.36001 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

248.524.36006 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

248.524.36003 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

248.524.36002 Boehringer Ingelheim Investigational Site

Zalaegerszeg, Hungary

Location

248.524.91002 Boehringer Ingelheim Investigational Site

Chennai, India

Location

248.524.91009 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

248.524.91010 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

248.524.91001 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

248.524.91005 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

248.524.91007 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

248.524.91004 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

248.524.91006 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

248.524.91011 Boehringer Ingelheim Investigational Site

Pune, India

Location

248.524.81010 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

Location

248.524.81001 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

248.524.81005 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, Japan

Location

248.524.81011 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, Japan

Location

248.524.81013 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

248.524.81015 Boehringer Ingelheim Investigational Site

Iwamizawa,Hokkaido, Japan

Location

248.524.81003 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, Japan

Location

248.524.81014 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

248.524.81009 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

248.524.81008 Boehringer Ingelheim Investigational Site

Okayama, Okayama, Japan

Location

248.524.81006 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, Japan

Location

248.524.81004 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

248.524.81007 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, Japan

Location

248.524.81012 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, Japan

Location

248.524.81002 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

248.524.60001 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

248.524.60004 Boehringer Ingelheim Investigational Site

Kuala Terengganu, Malaysia

Location

248.524.60002 Boehringer Ingelheim Investigational Site

Pulau Pinang, Malaysia

Location

248.524.07001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.524.07002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.524.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.524.07004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.524.07005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.524.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.524.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, Slovakia

Location

248.524.42101 Boehringer Ingelheim Investigational Site

Trnava, Slovakia

Location

248.524.88603 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

248.524.88605 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

248.524.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

248.524.88602 Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

248.524.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

248.524.38001 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

248.524.38002 Boehringer Ingelheim Investigational Site

Uzhhorod, Ukraine

Location

248.524.38003 Boehringer Ingelheim Investigational Site

Vinnytzya, Ukraine

Location

248.524.38004 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

248.524.38006 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2008
• Last Updated: July 17, 2014
• Results First Posted: April 15, 2010

Record last verified: 2014-06

Locations

SL (2); TW (4); IN (9); DE (9); AR (8); CZ (4); JP (15); MY (3); AU (2); UA (6); FI (3); HU (8); RU (6); US (16)