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

NCT00601523 | Completed Phase 3 Results

• 2 other identifiers: 248.6332007-004234-16
• Study Type: interventional
• Target: 511
• Locations: 15 countries
• Sites: 119

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

  80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

Secondary Outcomes (13)

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

  Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

• 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)

  OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

• UPDRS I Total Score: Change From OL Baseline

  OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

• UPDRS II Total Score: Change From OL Baseline

  OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

• UPDRS III Total Score: Change From OL Baseline

  OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

Study Arms (2)

Pramipexole

ACTIVE COMPARATOR

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

Drug: Pramipexole

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

Pramipexole DRUG

ER 0.375-4,5 mg

Pramipexole

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (119)

248.633.01004 Boehringer Ingelheim Investigational Site

Sun City, Arizona, United States

Location

248.633.01018 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Location

248.633.01016 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

248.633.01013 Boehringer Ingelheim Investigational Site

Oxnard, California, United States

Location

248.633.01008 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Location

248.633.01010 Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Location

248.633.01012 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.633.01001 Boehringer Ingelheim Investigational Site

Kansas City, Kansas, United States

Location

248.633.01005 Boehringer Ingelheim Investigational Site

Commack, New York, United States

Location

248.633.01009 Boehringer Ingelheim Investigational Site

Burlington, Vermont, United States

Location

248.633.43001 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

248.633.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

248.633.42004 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

248.633.42003 Boehringer Ingelheim Investigational Site

Pardubice, Czechia

Location

248.633.42001 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

248.633.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, Czechia

Location

248.633.35803 Boehringer Ingelheim Investigational Site

Hyvinkää, Finland

Location

248.633.35801 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.633.35802 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

248.633.3303A Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

248.633.3303B Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

248.633.3303C Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

248.633.3309A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

248.633.3309B Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

248.633.3305A Boehringer Ingelheim Investigational Site

Créteil, France

Location

248.633.3305B Boehringer Ingelheim Investigational Site

Créteil, France

Location

248.633.3313A Boehringer Ingelheim Investigational Site

Dijon, France

Location

248.633.3304A Boehringer Ingelheim Investigational Site

Évreux, France

Location

248.633.3308A Boehringer Ingelheim Investigational Site

Lille, France

Location

248.633.3308B Boehringer Ingelheim Investigational Site

Lille, France

Location

248.633.3308C Boehringer Ingelheim Investigational Site

Lille, France

Location

248.633.3308D Boehringer Ingelheim Investigational Site

Lille, France

Location

248.633.3308E Boehringer Ingelheim Investigational Site

Lille, France

Location

248.633.3302A Boehringer Ingelheim Investigational Site

Marseille, France

Location

248.633.3302B Boehringer Ingelheim Investigational Site

Marseille, France

Location

248.633.3302C Boehringer Ingelheim Investigational Site

Marseille, France

Location

248.633.3306B Boehringer Ingelheim Investigational Site

Montpellier, France

Location

248.633.3306C Boehringer Ingelheim Investigational Site

Montpellier, France

Location

248.633.3306D Boehringer Ingelheim Investigational Site

Montpellier, France

Location

248.633.3306F Boehringer Ingelheim Investigational Site

Montpellier, France

Location

248.633.3306A Boehringer Ingelheim Investigational Site

Montpellier Cédex 5, France

Location

248.633.3312A Boehringer Ingelheim Investigational Site

Rouen, France

Location

248.633.3312B Boehringer Ingelheim Investigational Site

Rouen, France

Location

248.633.3311A Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

248.633.3311B Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

248.633.3301A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.633.3301B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.633.3301C Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.633.3301D Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.633.3301F Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.633.3301G Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.633.49009 Boehringer Ingelheim Investigational Site

Achim Bei Bremen, Germany

Location

248.633.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.633.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.633.49018 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.633.49019 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.633.49005 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

248.633.49016 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

248.633.49007 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

248.633.49011 Boehringer Ingelheim Investigational Site

Gera, Germany

Location

248.633.49017 Boehringer Ingelheim Investigational Site

Karlsruhe, Germany

Location

248.633.49001 Boehringer Ingelheim Investigational Site

Kassel, Germany

Location

248.633.49012 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

248.633.49013 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

248.633.49003 Boehringer Ingelheim Investigational Site

Steglitz, Germany

Location

248.633.49015 Boehringer Ingelheim Investigational Site

Unterhaching, Germany

Location

248.633.36007 Boehringer Ingelheim Investigational Site

Eger, Hungary

Location

248.633.36005 Boehringer Ingelheim Investigational Site

Győr, Hungary

Location

248.633.36008 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

248.633.36004 Boehringer Ingelheim Investigational Site

Sopron, Hungary

Location

248.633.36001 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

248.633.36006 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

248.633.36003 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

248.633.36002 Boehringer Ingelheim Investigational Site

Zalaegerszeg, Hungary

Location

248.633.91002 Boehringer Ingelheim Investigational Site

Chennai, India

Location

248.633.91009 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

248.633.91001 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

248.633.91005 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

248.633.91007 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

248.633.91004 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

248.633.91011 Boehringer Ingelheim Investigational Site

Pune, India

Location

248.633.81010 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

Location

248.633.81001 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

248.633.81005 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, Japan

Location

248.633.81011 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, Japan

Location

248.633.81013 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

248.633.81015 Boehringer Ingelheim Investigational Site

Iwamizawa,Hokkaido, Japan

Location

248.633.81003 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, Japan

Location

248.633.81014 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

248.633.81009 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

248.633.81008 Boehringer Ingelheim Investigational Site

Okayama, Okayama, Japan

Location

248.633.81006 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, Japan

Location

248.633.81004 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

248.633.81007 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, Japan

Location

248.633.81012 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, Japan

Location

248.633.81002 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, Japan

Location

248.633.60004 Boehringer Ingelheim Investigational Site

Kuala Terengganu, Malaysia

Location

248.633.31002 Boehringer Ingelheim Investigational Site

Geldrop, Netherlands

Location

248.633.31003 Boehringer Ingelheim Investigational Site

Helmond, Netherlands

Location

248.633.31006 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

248.633.31004 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

248.633.31001 Boehringer Ingelheim Investigational Site

Sittard-geleen, Netherlands

Location

248.633.07001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.633.07002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.633.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.633.07004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.633.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.633.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, Slovakia

Location

248.633.42101 Boehringer Ingelheim Investigational Site

Trnava, Slovakia

Location

248.633.88603 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

248.633.88605 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

248.633.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

248.633.88602 Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

248.633.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

248.633.38001 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

248.633.38002 Boehringer Ingelheim Investigational Site

Uzhhorod, Ukraine

Location

248.633.38003 Boehringer Ingelheim Investigational Site

Vinnytzya, Ukraine

Location

248.633.38004 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

248.633.38006 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Last Updated: June 9, 2014
• Results First Posted: August 25, 2011

Record last verified: 2014-03

Locations

IN (7); FR (32); JP (15); NL (5); SL (2); US (10); CZ (4); HU (8); AU (2); FI (3); MY (1); DE (15); TW (4); RU (5); UA (6)