An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up

Conditions: Parkinson?s disease
MedDRA version: 12.0Level: LLTClassification code 10013113Term: Disease Parkinson's

Registration Number: EUCTR2009-011541-24-IT

Lead Sponsor: Teva Pharmaceutical Industries Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

Subjects who participated in the ADAGIO study, and who entered the active phase of the study and 2) Subjects who are currently on rasagiline treatment (or subjects who have stopped rasagiline treatment, are willing to restart treatment, and in the opinion of the investigator will gain clinical benefit from restarting treatment) and 3) Subjects with a diagnosis of Parkinson?s disease and 4) Subjects willing and able to give written 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

Exclusion Criteria

Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently. 2) Subjects who cannot be given rasagiline due to any exclusion based on the local label (including pregnancy or nursing women) or due to the use of medications contraindicated for concomitant use with rasagiline according to local label 3) Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether the effect of early-start rasagiline treatment (according to the ADAGIO study protocol) provided long-term benefits over delayed-start. <br>To investigate the long-term effects of rasagiline in PD subjects who participated in the ADAGIO study and have continued on rasagiline treatment.;Secondary Objective: ;Primary end point(s): There is no primary end-point in this study. The main outcome analysis will be of the emergence of the following milestones since the last assessment (short or long visit) per subject report: Unsteady gait and balance Falls Freezing of gait Cognitive decline (at least two positive answers for the cognitive function questions).For these outcome measures descriptive statistics will be supplied as well as Kaplan-Meier plots of time to first emergence.

Secondary Outcome Measures