Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
- NCT00601523
- PHASE3
- INTERVENTIONAL
Last updated: 2014-06-09
Purpose of Trial
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).
This study is for people with
Parkinson Disease
Interventions being studied
Placebo
Pramipexole
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 Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.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.
ELIGIBILITY
Gender: ALL
Age: 30+
Healthy Volunteers: No
10 Locations
Sun City
248.633.01004 Boehringer Ingelheim Investigational Site
Arizona, United States
Tempe
248.633.01018 Boehringer Ingelheim Investigational Site
Arizona, United States
La Jolla
248.633.01016 Boehringer Ingelheim Investigational Site
California, United States
Oxnard
248.633.01013 Boehringer Ingelheim Investigational Site
California, United States
Danbury
248.633.01008 Boehringer Ingelheim Investigational Site
Connecticut, United States
Boca Raton
248.633.01010 Boehringer Ingelheim Investigational Site
Florida, United States
Chicago
248.633.01012 Boehringer Ingelheim Investigational Site
Illinois, United States
Kansas City
248.633.01001 Boehringer Ingelheim Investigational Site
Kansas, United States
Commack
248.633.01005 Boehringer Ingelheim Investigational Site
New York, United States
Burlington
248.633.01009 Boehringer Ingelheim Investigational Site
Vermont, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov