Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patient with idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. Parkinson’s disease diagnosed within 5 years. Patients 30 years of age or older at the time of diagnosis. Modified Hoehn and Yahr stage of 1 to 3. Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrolment according to the investigator’s judgement. Patients 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 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: 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). Dementia, as defined by a Mini-Mental State Exam score 2 ULN (on screening lab test). Patients with a creatinine clearance < 50 mL/min (estimated by the MDRD (Modification of Diet in Renal Disease) formula and calculated by the central lab on screening lab test) Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit. Total cumulative duration of prior exposure to Levodopa of more than 3 months. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc). Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines. Flunarizine within 3 months prior to baseline visit. Known hypersensitivity to Pramipexole or its excipients. Drug abuse (including alcohol), according to Investigator’s judgement, within 2 years prior to screening. Participation in other investigational drug studies 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 visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy (as measured by the change from baseline in the total score for UPDRS parts II and III combined), safety and tolerability of Pramipexole ER compared with placebo and Pramipexole IR in patients with early Parkinson's disease. Superiority of pramipexole ER to placebo (at 18 weeks) and non-inferiority of pramipexole ER to IR (at 33 weeks) will be evaluated in a hierarchical system of hypotheses.;Secondary Objective: Cost-effectiveness analysis Pramipexole plasma concentrations (exposure) will be assessed ;Primary end point(s): The primary efficacy endpoint of the trial is the change from baseline in UPDRS part II+III score: - for the superiority hypothesis (pramipexole ER vs. placebo): change form baseline to week 18 (Visit 8) - for the non-inferiority hypothesis (pramipexole ER vs. pramipecole IR): change from baseline to the end of the maintenance phase at week 33 (Visit 11) | — |
Countries
Austria, Czech Republic, Finland, Germany, Hungary
Outcome results
None listed