Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion criteria:
- 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).
Exclusion criteria:
- Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.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.
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.
Sites / Locations
- 248.633.01004 Boehringer Ingelheim Investigational Site
- 248.633.01018 Boehringer Ingelheim Investigational Site
- 248.633.01016 Boehringer Ingelheim Investigational Site
- 248.633.01013 Boehringer Ingelheim Investigational Site
- 248.633.01008 Boehringer Ingelheim Investigational Site
- 248.633.01010 Boehringer Ingelheim Investigational Site
- 248.633.01012 Boehringer Ingelheim Investigational Site
- 248.633.01001 Boehringer Ingelheim Investigational Site
- 248.633.01005 Boehringer Ingelheim Investigational Site
- 248.633.01009 Boehringer Ingelheim Investigational Site
- 248.633.43001 Boehringer Ingelheim Investigational Site
- 248.633.43004 Boehringer Ingelheim Investigational Site
- 248.633.42004 Boehringer Ingelheim Investigational Site
- 248.633.42003 Boehringer Ingelheim Investigational Site
- 248.633.42001 Boehringer Ingelheim Investigational Site
- 248.633.42002 Boehringer Ingelheim Investigational Site
- 248.633.35803 Boehringer Ingelheim Investigational Site
- 248.633.35801 Boehringer Ingelheim Investigational Site
- 248.633.35802 Boehringer Ingelheim Investigational Site
- 248.633.3303A Boehringer Ingelheim Investigational Site
- 248.633.3303B Boehringer Ingelheim Investigational Site
- 248.633.3303C Boehringer Ingelheim Investigational Site
- 248.633.3309A Boehringer Ingelheim Investigational Site
- 248.633.3309B Boehringer Ingelheim Investigational Site
- 248.633.3305A Boehringer Ingelheim Investigational Site
- 248.633.3305B Boehringer Ingelheim Investigational Site
- 248.633.3313A Boehringer Ingelheim Investigational Site
- 248.633.3304A Boehringer Ingelheim Investigational Site
- 248.633.3308A Boehringer Ingelheim Investigational Site
- 248.633.3308B Boehringer Ingelheim Investigational Site
- 248.633.3308C Boehringer Ingelheim Investigational Site
- 248.633.3308D Boehringer Ingelheim Investigational Site
- 248.633.3308E Boehringer Ingelheim Investigational Site
- 248.633.3302A Boehringer Ingelheim Investigational Site
- 248.633.3302B Boehringer Ingelheim Investigational Site
- 248.633.3302C Boehringer Ingelheim Investigational Site
- 248.633.3306A Boehringer Ingelheim Investigational Site
- 248.633.3306B Boehringer Ingelheim Investigational Site
- 248.633.3306C Boehringer Ingelheim Investigational Site
- 248.633.3306D Boehringer Ingelheim Investigational Site
- 248.633.3306F Boehringer Ingelheim Investigational Site
- 248.633.3312A Boehringer Ingelheim Investigational Site
- 248.633.3312B Boehringer Ingelheim Investigational Site
- 248.633.3311A Boehringer Ingelheim Investigational Site
- 248.633.3311B Boehringer Ingelheim Investigational Site
- 248.633.3301C Boehringer Ingelheim Investigational Site
- 248.633.3301B Boehringer Ingelheim Investigational Site
- 248.633.3301A Boehringer Ingelheim Investigational Site
- 248.633.3301D Boehringer Ingelheim Investigational Site
- 248.633.3301F Boehringer Ingelheim Investigational Site
- 248.633.3301G Boehringer Ingelheim Investigational Site
- 248.633.49009 Boehringer Ingelheim Investigational Site
- 248.633.49003 Boehringer Ingelheim Investigational Site
- 248.633.49002 Boehringer Ingelheim Investigational Site
- 248.633.49004 Boehringer Ingelheim Investigational Site
- 248.633.49018 Boehringer Ingelheim Investigational Site
- 248.633.49019 Boehringer Ingelheim Investigational Site
- 248.633.49005 Boehringer Ingelheim Investigational Site
- 248.633.49016 Boehringer Ingelheim Investigational Site
- 248.633.49007 Boehringer Ingelheim Investigational Site
- 248.633.49011 Boehringer Ingelheim Investigational Site
- 248.633.49017 Boehringer Ingelheim Investigational Site
- 248.633.49001 Boehringer Ingelheim Investigational Site
- 248.633.49012 Boehringer Ingelheim Investigational Site
- 248.633.49013 Boehringer Ingelheim Investigational Site
- 248.633.49015 Boehringer Ingelheim Investigational Site
- 248.633.36007 Boehringer Ingelheim Investigational Site
- 248.633.36005 Boehringer Ingelheim Investigational Site
- 248.633.36008 Boehringer Ingelheim Investigational Site
- 248.633.36004 Boehringer Ingelheim Investigational Site
- 248.633.36001 Boehringer Ingelheim Investigational Site
- 248.633.36006 Boehringer Ingelheim Investigational Site
- 248.633.36003 Boehringer Ingelheim Investigational Site
- 248.633.36002 Boehringer Ingelheim Investigational Site
- 248.633.91002 Boehringer Ingelheim Investigational Site
- 248.633.91009 Boehringer Ingelheim Investigational Site
- 248.633.91001 Boehringer Ingelheim Investigational Site
- 248.633.91005 Boehringer Ingelheim Investigational Site
- 248.633.91007 Boehringer Ingelheim Investigational Site
- 248.633.91004 Boehringer Ingelheim Investigational Site
- 248.633.91011 Boehringer Ingelheim Investigational Site
- 248.633.81010 Boehringer Ingelheim Investigational Site
- 248.633.81001 Boehringer Ingelheim Investigational Site
- 248.633.81005 Boehringer Ingelheim Investigational Site
- 248.633.81011 Boehringer Ingelheim Investigational Site
- 248.633.81013 Boehringer Ingelheim Investigational Site
- 248.633.81015 Boehringer Ingelheim Investigational Site
- 248.633.81003 Boehringer Ingelheim Investigational Site
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- 248.633.81004 Boehringer Ingelheim Investigational Site
- 248.633.81007 Boehringer Ingelheim Investigational Site
- 248.633.81012 Boehringer Ingelheim Investigational Site
- 248.633.81002 Boehringer Ingelheim Investigational Site
- 248.633.60004 Boehringer Ingelheim Investigational Site
- 248.633.31002 Boehringer Ingelheim Investigational Site
- 248.633.31003 Boehringer Ingelheim Investigational Site
- 248.633.31006 Boehringer Ingelheim Investigational Site
- 248.633.31004 Boehringer Ingelheim Investigational Site
- 248.633.31001 Boehringer Ingelheim Investigational Site
- 248.633.07001 Boehringer Ingelheim Investigational Site
- 248.633.07002 Boehringer Ingelheim Investigational Site
- 248.633.07003 Boehringer Ingelheim Investigational Site
- 248.633.07004 Boehringer Ingelheim Investigational Site
- 248.633.07006 Boehringer Ingelheim Investigational Site
- 248.633.42103 Boehringer Ingelheim Investigational Site
- 248.633.42101 Boehringer Ingelheim Investigational Site
- 248.633.88603 Boehringer Ingelheim Investigational Site
- 248.633.88605 Boehringer Ingelheim Investigational Site
- 248.633.88601 Boehringer Ingelheim Investigational Site
- 248.633.88602 Boehringer Ingelheim Investigational Site
- 248.633.38005 Boehringer Ingelheim Investigational Site
- 248.633.38001 Boehringer Ingelheim Investigational Site
- 248.633.38002 Boehringer Ingelheim Investigational Site
- 248.633.38003 Boehringer Ingelheim Investigational Site
- 248.633.38004 Boehringer Ingelheim Investigational Site
- 248.633.38006 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Pramipexole
Placebo
Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.