ong-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).
- Conditions
- Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease
- Registration Number
- EUCTR2007-004234-16-FR
- Lead Sponsor
- BOEHRINGER INGELHEIM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
Completion of trial 248.524 or 248.636.
Male or female with early idiopathic Parkinson´s disease and with Modified Hoehn and Yahr stage I-III.
Patients willing and able to comply with the study procedures.
Signed informed consent.
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
Premature withdrawal from study 248.524 or 248.636.
Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the study and/or put patient at risk if he/she takes part in the study.
History of psychosis, except history of drug induced hallucinations.
Clinically significant ECG abnormalities.
Clinically significant hypotension (i.e. supine blood pressure<90 mmHg) and/or symptomatic orthostatic hypotension (i.e. clinical symptoms of orthostatic hypotension 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) at baseline.
Malignant melanoma or history of previously treated malignant melanoma.
Any other clinically significant disease that could put the patient at risk or could prevent compliance or completion of the study.
Pregnancy and breast-feeding.
Sexually active female of childbearing potential not using medically approved method of birth control.
Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatase or bilirubin > 2 ULN at baseline.
Patients with creatinine clearance < 50 mL/min.
Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.
Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit.
Methylphenidate, cinnarizine, amphetamines within 4 weeks prior to baseline.
Flunarizine within 3 months prior to baseline.
Known hypersensitivity to pramipexole or its excipients.
Drug abuse (including alcohol) according to investigator´s judgement, within 2 years prior to baseline.
Participation in investigational drug studies, other than 248.524 and 248.636, 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To obtain long term safety and tolerability data on pramipexole ER in patients who have previously completed a pramipexole double-blind study in early PD (248.524 or 248.636 trial);Secondary Objective: To assess if patients treated with pramipexole for 12 months (6 months in the previous DB trial 248.524 and then 6 months in the 248.633 trial) demonstrate less functional decline than patients whose treatment was delayed for 6 months (i.e. patients treated with placebo in the previous DB-trial 248.524).<br>To assess dose adjustments and effects on other efficacy criteria during long-term treatment with pramipexole ER.;Primary end point(s): No primary efficacy endpoint is set up, because the primary objective of this trial is to obtain long-term safety and tolerability data.
- Secondary Outcome Measures
Name Time Method