ong-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND
- Conditions
- Patients with advanced idiopathic PDMedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease
- Registration Number
- EUCTR2007-004235-37-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
Male or female patients with advanced idiopathic PD, who have completed trial 248.525 (EudraCT n. 2007-000074-23), have a modified Hoehn and Yahr scale of II to IV at on-time and are treated with L-Dopa+ (i.e. standard and/or controlled release Levodopa/DDC inhibitor), or with a combination of L-Dopa+ and entacapone. A concomitant treatment with one or more of the following drugs will be allowed. If possible, it should remain at a stable dose during the study, however patients will not be dropped if the dose of such medication is altered: - anti-Parkinsonian anticholinergics; - selegiline, rasagiline, or other MAO-B-Inhibitor; - amantadine; - entacapone (or other COMT-Inhibitor); - beta-blockers (e.g. propranolol) when used to treat PD (for tremor symptoms).
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
-Patients prematurely withdrawn from the double-blind trial 248.525 (whatever the reason), will not be allowed to enter the open-label extension study. -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). -Any psychiatric disorder according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study. -History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation to the trial would not represent a significant risk for the patient). -History of deep brain stimulation. -Clinically significant electrocardiogram (ECG) abnormalities at baseline according to investigator?s judgement. -Clinically significant hypotension (i.e. supine systolic 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, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study. -Pregnancy (to be excluded by urine pregnancy test at baseline) or breast-feeding. -Sexually active female of childbearing potential (less than 6 months post-menopausal and not surgically sterilized) not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study. -Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN at baseline. -Patients with a creatinine clearance < 50 mL/min at baseline. -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. -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 the trial 248.525, 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
- Secondary Outcome Measures
Name Time Method