Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Completion of trial 248.524 or 248.636. Male or female with early idiopathic Parkinson´s disease and with Modified Hoehn and Yahr stage I-III. Patients willing and able to comply with the study procedures. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Premature withdrawal from study 248.524 or 248.636. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases. Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the study and/or put patient at risk if he/she takes part in the study. History of psychosis, except history of drug induced hallucinations. Clinically significant ECG abnormalities. Clinically significant hypotension (i.e. supine blood pressure 2 ULN at baseline. Patients with creatinine clearance < 50 mL/min. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. Methylphenidate, cinnarizine, amphetamines within 4 weeks prior to baseline. Flunarizine within 3 months prior to baseline. Known hypersensitivity to pramipexole or its excipients. Drug abuse (including alcohol) according to investigator´s judgement, within 2 years prior to baseline. Participation in investigational drug studies, other than 248.524 and 248.636, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 or 248.636 trial);Secondary Objective: To assess if patients treated with pramipexole for 12 months (6 months in the previous DB trial 248.524 and then 6 months in the 248.633 trial) demonstrate less functional decline than patients whose treatment was delayed for 6 months (i.e. patients treated with placebo in the previous DB-trial 248.524). To assess dose adjustments and effects on other efficacy criteria during long-term treatment with pramipexole ER.;Primary end point(s): No primary efficacy endpoint is set up, because the primary objective of this trial is to obtain long-term safety and tolerability data. | — |
Countries
Austria, Czech Republic, Finland, France, Hungary, Netherlands
Outcome results
None listed