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

Boehringer Ingelheim AB0 sites390 target enrollmentMarch 25, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: Boehringer Ingelheim AB
Enrollment: 390
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 25, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•Patients prematurely withdrawn from the double\-blind trial 248\.525, will not be allowed to enter the open\-label extension study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