Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Completion of the double-blind trial 248.525 Male or female patient with advanced idiopathic Parkinson’s disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the offtime and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary. Signed informed consent obtained before any study procedures are carried out (in accordance with ICH-GCP guidelines and local legislation). 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Exclusion criteria: Patients prematurely withdrawn from the double-blind trial 248.525, will not be allowed to enter the open-label extension study Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) Any psychiatric disorder according to 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 History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation to the trial would not represent a significant risk for the patient) History of deep brain stimulation Clinically significant electrocardiogram (ECG) abnormalities at baseline according to investigator’s judgement Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline Malignant melanoma or history of previously treated malignant melanoma Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study 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 Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN at visit 6 in trial 248.525 Patients with a creatinine clearance < 50 mL/min (estimated either by the MDRD (Modification of Diet in Renal Disease) formula, or by the Cockcroft and Gault formula, depending on the formula used in the 248.525 trial for each patient, and calculated by the central lab on screening lab test) Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines Flunarizine within 3 months prior to baseline Known hypersensitivity to pramipexole or its excipients. Drug abuse, according to investigator’s judgement, within 2 years prior to baseline Participation in investigational drug studies other than the trial 248.525, 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: The primary objective of this trial is to obtain long-term safety and tolerability data on pramipexole ER in patients who have previously participated in a pramipexole double-blind (DB) study in advanced PD;Primary end point(s): The primary objective of this trial is to obtain long-term safety and tolerability data on pramipexole ER in patients who have previously participated in a pramipexole double-blind study in advanced PD (248.525 trial).;Secondary Objective: Percentage of patients successfully switched (within one week) from pramipexole ER or IR to pramipexole ER, regarding the UPDRS II+III score and off-time. UPDRS parts II+III score Percentage off-time during waking hours Proportion of patients with at least a 20% improvement relative to baseline in the percentage off-time during waking hours Percentage on-time: without dyskinesia; with non troublesome dyskinesia; without dyskinesia or with non-troublesome dyskinesia; with troublesome dyskinesia; during waking hours Response in CGI-I, PGI-I and PGI-I for early morning off-symptoms UPDRS I, II, III and IV scores separately PFS-16 Proportion of patients with at least a 20% improvement relative to baseline in the UPDRS II+III total score incidences of Adverse Events (AEs) proportions of withdrawals due to AEs vital signs and weight ESS | — |
Countries
Austria, Czech Republic, Hungary, Italy, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed