ong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD
- Conditions
- 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: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease
- Registration Number
- EUCTR2007-004235-37-PL
- Lead Sponsor
- Boehringer Ingelheim Pharma Ges mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
Completion of the double-blind trial 248.525
Male or female patient with advanced idiopathic Parkinson’s disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the offtime and on-time periods during waking hours and the patient (or a family member or a guardian) should be 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
Patients prematurely withdrawn from the double-blind trial 248.525, will not be allowed to enter the open-label extension study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 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 and/or symptomatic orthostatic hypotension 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 or breast-feeding
Sexually active female of childbearing potential 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 with central dopaminergic
antagonist activity within 4 weeks prior to the baseline visit
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, 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