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

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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).

Key facts

Study ID

NCT00601523

Run by

Boehringer Ingelheim

People needed

511

Starts

2008-01-01

Last updated by the study team

2014-06-09

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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• Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.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.

Where it is running

• 248.633.01018 Boehringer Ingelheim Investigational Site — Tempe, Arizona, United States
• 248.633.01016 Boehringer Ingelheim Investigational Site — La Jolla, California, United States
• 248.633.01013 Boehringer Ingelheim Investigational Site — Oxnard, California, United States
• 248.633.01008 Boehringer Ingelheim Investigational Site — Danbury, Connecticut, United States
• 248.633.01010 Boehringer Ingelheim Investigational Site — Boca Raton, Florida, United States
• 248.633.01012 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 248.633.01001 Boehringer Ingelheim Investigational Site — Kansas City, Kansas, United States
• 248.633.01005 Boehringer Ingelheim Investigational Site — Commack, New York, United States
• 248.633.01009 Boehringer Ingelheim Investigational Site — Burlington, Vermont, United States
• 248.633.43001 Boehringer Ingelheim Investigational Site — Innsbruck, Austria
• 248.633.43004 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 248.633.42004 Boehringer Ingelheim Investigational Site — Olomouc, Czechia
• 248.633.42003 Boehringer Ingelheim Investigational Site — Pardubice, Czechia
• 248.633.42001 Boehringer Ingelheim Investigational Site — Prague, Czechia
• 248.633.42002 Boehringer Ingelheim Investigational Site — Rychnov nad Kněžnou, Czechia
• 248.633.35803 Boehringer Ingelheim Investigational Site — Hyvinkää, Finland
• 248.633.35801 Boehringer Ingelheim Investigational Site — Oulu, Finland
• 248.633.35802 Boehringer Ingelheim Investigational Site — Tampere, Finland
• 248.633.3303A Boehringer Ingelheim Investigational Site — Aix-en-Provence, France
• 248.633.3303B Boehringer Ingelheim Investigational Site — Aix-en-Provence, France
• 248.633.3303C Boehringer Ingelheim Investigational Site — Aix-en-Provence, France
• 248.633.3309A Boehringer Ingelheim Investigational Site — Clermont-Ferrand, France
• 248.633.3309B Boehringer Ingelheim Investigational Site — Clermont-Ferrand, France
• 248.633.3305A Boehringer Ingelheim Investigational Site — Créteil, France
• 248.633.01004 Boehringer Ingelheim Investigational Site — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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