Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. 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: 1. Male or female patient with idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. 2. Parkinson’s disease diagnosed within 5 years. 3. Patients 30 years of age or older at the time of diagnosis. 4. Modified Hoehn and Yahr stage of 1 to 3. 5. Patients receiving pramipexole IR at least three months prior to baseline visit (randomization visit, V2) 6. Pramipexole dose should optimized according to the investigator’s judgement, greater or equal to 1.5 per day, stable and equally divided times a day, for at least 4 weeks prior to baseline visit (V2) 7. Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 8. 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: Medical exclusions: 1. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at screening visit 2. 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). 3. Dementia, as defined by a Mini-Mental State Exam score 2 ULN (on screening lab test). 13. Patients with a creatinine clearance < 50 mL/min (estimated by the Cockcroft and Gault formula and calculated by the local lab or by the investigator on screening lab test) Pharmacological exclusions: 14. Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit. The following concomitant PD treatments are allowed, provided they are at a stable dose for at least 4 weeks prior to baseline and the investigator does not intend to change this treatment during the treatment phase: L-Dopa+, and/or anti-Parkinsonian anticholinergics, and/or selegiline, rasagiline, or other MAO-B Inhibitors, and/or amantadine, and/or entacapone (or other COMT-Inhibitors), and/or beta-blocke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole Immediate Release formulation (IR) to Pramipexole Extended Release formulation (ER), and to establish if this successful switch can be obtained with or without dose adaptation.;Secondary Objective: Secondary objectives of the trial are to provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER, to assess safety and tolerability of switching patients with early Parkinson's disease from Pramipexole IR to Pramipexole ER.;Primary end point(s): The primary efficacy endpoint is the proportion of patients successfully switched from pramipexole IR to pramipexole ER or IR at the end of the double-blind treatment phase or maintenance N° 2 (visit 5). | — |
Countries
France, Germany, Netherlands
Outcome results
None listed