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

NCT ID: NCT00601523

Last Updated: 2014-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pramipexole

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

Group Type ACTIVE_COMPARATOR

Pramipexole

Intervention Type DRUG

ER 0.375-4,5 mg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Pramipexole

ER 0.375-4,5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Completion of the double-blind trial 248.524 or 248.636
2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. 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).

Exclusion Criteria

1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
2. Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
3. 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.

5\. 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.

10\. 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.

14\. 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.

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

19\. 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.
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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248.633.01004 Boehringer Ingelheim Investigational Site

Sun City, Arizona, United States

Site Status

248.633.01018 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Site Status

248.633.01016 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Site Status

248.633.01013 Boehringer Ingelheim Investigational Site

Oxnard, California, United States

Site Status

248.633.01008 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Site Status

248.633.01010 Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Site Status

248.633.01012 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

248.633.01001 Boehringer Ingelheim Investigational Site

Kansas City, Kansas, United States

Site Status

248.633.01005 Boehringer Ingelheim Investigational Site

Commack, New York, United States

Site Status

248.633.01009 Boehringer Ingelheim Investigational Site

Burlington, Vermont, United States

Site Status

248.633.43001 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

Site Status

248.633.43004 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

248.633.42004 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

Site Status

248.633.42003 Boehringer Ingelheim Investigational Site

Pardubice, , Czechia

Site Status

248.633.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

248.633.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, , Czechia

Site Status

248.633.35803 Boehringer Ingelheim Investigational Site

Hyvinkää, , Finland

Site Status

248.633.35801 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

248.633.35802 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

248.633.3303A Boehringer Ingelheim Investigational Site

Aix-en-Provence, , France

Site Status

248.633.3303B Boehringer Ingelheim Investigational Site

Aix-en-Provence, , France

Site Status

248.633.3303C Boehringer Ingelheim Investigational Site

Aix-en-Provence, , France

Site Status

248.633.3309A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

Site Status

248.633.3309B Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

Site Status

248.633.3305A Boehringer Ingelheim Investigational Site

Créteil, , France

Site Status

248.633.3305B Boehringer Ingelheim Investigational Site

Créteil, , France

Site Status

248.633.3313A Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

248.633.3304A Boehringer Ingelheim Investigational Site

Évreux, , France

Site Status

248.633.3308A Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

248.633.3308B Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

248.633.3308C Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

248.633.3308D Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

248.633.3308E Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

248.633.3302A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

248.633.3302B Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

248.633.3302C Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

248.633.3306B Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

248.633.3306C Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

248.633.3306D Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

248.633.3306F Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

248.633.3306A Boehringer Ingelheim Investigational Site

Montpellier Cédex 5, , France

Site Status

248.633.3312A Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

248.633.3312B Boehringer Ingelheim Investigational Site

Rouen, , France

Site Status

248.633.3311A Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

248.633.3311B Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

248.633.3301A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

248.633.3301B Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

248.633.3301C Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

248.633.3301D Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

248.633.3301F Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

248.633.3301G Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

248.633.49009 Boehringer Ingelheim Investigational Site

Achim Bei Bremen, , Germany

Site Status

248.633.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

248.633.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

248.633.49018 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

248.633.49019 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

248.633.49005 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

248.633.49016 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

248.633.49007 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

248.633.49011 Boehringer Ingelheim Investigational Site

Gera, , Germany

Site Status

248.633.49017 Boehringer Ingelheim Investigational Site

Karlsruhe, , Germany

Site Status

248.633.49001 Boehringer Ingelheim Investigational Site

Kassel, , Germany

Site Status

248.633.49012 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

248.633.49013 Boehringer Ingelheim Investigational Site

Marburg, , Germany

Site Status

248.633.49003 Boehringer Ingelheim Investigational Site

Steglitz, , Germany

Site Status

248.633.49015 Boehringer Ingelheim Investigational Site

Unterhaching, , Germany

Site Status

248.633.36007 Boehringer Ingelheim Investigational Site

Eger, , Hungary

Site Status

248.633.36005 Boehringer Ingelheim Investigational Site

Győr, , Hungary

Site Status

248.633.36008 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

Site Status

248.633.36004 Boehringer Ingelheim Investigational Site

Sopron, , Hungary

Site Status

248.633.36001 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

248.633.36006 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

248.633.36003 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

Site Status

248.633.36002 Boehringer Ingelheim Investigational Site

Zalaegerszeg, , Hungary

Site Status

248.633.91002 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

248.633.91009 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

248.633.91001 Boehringer Ingelheim Investigational Site

Karnataka, , India

Site Status

248.633.91005 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

248.633.91007 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

248.633.91004 Boehringer Ingelheim Investigational Site

New Delhi, , India

Site Status

248.633.91011 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

248.633.81010 Boehringer Ingelheim Investigational Site

Aomori, Aomori, , Japan

Site Status

248.633.81001 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, , Japan

Site Status

248.633.81005 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, , Japan

Site Status

248.633.81011 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, , Japan

Site Status

248.633.81013 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

248.633.81015 Boehringer Ingelheim Investigational Site

Iwamizawa,Hokkaido, , Japan

Site Status

248.633.81003 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, , Japan

Site Status

248.633.81014 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

248.633.81009 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

Site Status

248.633.81008 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

Site Status

248.633.81006 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, , Japan

Site Status

248.633.81004 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, , Japan

Site Status

248.633.81007 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, , Japan

Site Status

248.633.81012 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, , Japan

Site Status

248.633.81002 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, , Japan

Site Status

248.633.60004 Boehringer Ingelheim Investigational Site

Kuala Terengganu, , Malaysia

Site Status

248.633.31002 Boehringer Ingelheim Investigational Site

Geldrop, , Netherlands

Site Status

248.633.31003 Boehringer Ingelheim Investigational Site

Helmond, , Netherlands

Site Status

248.633.31006 Boehringer Ingelheim Investigational Site

Maastricht, , Netherlands

Site Status

248.633.31004 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

Site Status

248.633.31001 Boehringer Ingelheim Investigational Site

Sittard-geleen, , Netherlands

Site Status

248.633.07001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.633.07002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.633.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.633.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.633.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

248.633.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, , Slovakia

Site Status

248.633.42101 Boehringer Ingelheim Investigational Site

Trnava, , Slovakia

Site Status

248.633.88603 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

248.633.88605 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

248.633.88601 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

248.633.88602 Boehringer Ingelheim Investigational Site

Taoyuan District, , Taiwan

Site Status

248.633.38005 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

248.633.38001 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

248.633.38002 Boehringer Ingelheim Investigational Site

Uzhhorod, , Ukraine

Site Status

248.633.38003 Boehringer Ingelheim Investigational Site

Vinnytzya, , Ukraine

Site Status

248.633.38004 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

248.633.38006 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Countries

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

Other Identifiers

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2007-004234-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

248.633

Identifier Type: -

Identifier Source: org_study_id

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