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
Interventions
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Concentration unit: mg milli
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patient with advanced idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. Parkinson’s disease diagnosed for at least 2 years. Patients 30 years of age or older at the time of diagnosis. Modified Hoehn and Yahr stage of 2 to 4 at on-time. Treatment with standard or controlled release L-Dopa+, or with L-Dopa+/entacapone, at an optimised dose according to investigator’s judgement, this dose being stable for at least 4 weeks prior to baseline visit. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit). Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is 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: 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. 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 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 |
|---|---|
| Primary end point(s): UPDRS (Unified Parkinson’s Disease Rating Scale) parts II+III score (change from baseline to week 18 (Visit 8)).;Secondary Objective: In addition, a numerical comparison of the efficacy of Pramipexole ER versus Pramipexole IR will be done. Cost-effectiveness analysis will be conducted to compare treatments.;Main Objective: To determine the efficacy (as measured by the change from baseline to week 18 (Visit 8), in the total score for UPDRS parts II and III combined), safety and tolerability of Pramipexole ER compared with placebo in L-Dopa+ treated patients with advanced PD. | — |
Countries
Austria, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed