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Clinical Trials/EUCTR2007-004235-37-SE
EUCTR2007-004235-37-SEActive, not recruitingNot Applicable

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 enrollmentStarted: March 25, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
390
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Patients prematurely withdrawn from the double-blind trial 248.525, will not be allowed to enter the open-label extension study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

Investigators

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