A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion criteria
- Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.
- Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.
- Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).
Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:
- wearing-off phenomena
- no on /delayed on
- dystonia at off time
- on-off phenomena
- freezing phenomena at off time
- the sub-optimal dose of L-DOPA had been administered due to side effects (such as dyskinesia), or therapeutical strategy
Exclusion criteria
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- Dementia, as defined by a Mini-Mental State Examination (MMSE) score <24 at screening visit.
- Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.
- History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
- Clinically significant ECG abnormalities at screening visit, according to investigator's judgement.
- Clinically significant hypotension or symptomatic orthostatic hypotension (i.e., clinical symptoms of orthostatic hypotension such as dizziness postural etc associated with a decline >=20 mmHg in systolic blood pressure and a decline >=10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
- Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.
- Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
- Sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.
- Serum levels of AST, ALT, alkaline phosphatases or bilirubin >2 upper limits of normal .
- Patients with a creatinine clearance <50 mL/min
- Patients with a complication or signs of malignant tumours or those within 5 years after the treatment.
Sites / Locations
- 248.610.019 Boehringer Ingelheim Investigational Site
- 248.610.020 Boehringer Ingelheim Investigational Site
- 248.610.006 Boehringer Ingelheim Investigational Site
- 248.610.017 Boehringer Ingelheim Investigational Site
- 248.610.018 Boehringer Ingelheim Investigational Site
- 248.610.001 Boehringer Ingelheim Investigational Site
- 248.610.014 Boehringer Ingelheim Investigational Site
- 248.610.011 Boehringer Ingelheim Investigational Site
- 248.610.015 Boehringer Ingelheim Investigational Site
- 248.610.003 Boehringer Ingelheim Investigational Site
- 248.610.008 Boehringer Ingelheim Investigational Site
- 248.610.021 Boehringer Ingelheim Investigational Site
- 248.610.010 Boehringer Ingelheim Investigational Site
- 248.610.005 Boehringer Ingelheim Investigational Site
- 248.610.012 Boehringer Ingelheim Investigational Site
- 248.610.004 Boehringer Ingelheim Investigational Site
- 248.610.009 Boehringer Ingelheim Investigational Site
- 248.610.007 Boehringer Ingelheim Investigational Site
- 248.610.002 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pramipexole Extended Release
Pramipexole Immediate Release
patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID
patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID