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. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up

Phase 1

• Conditions: Parkinson's Disease Enfermedad de Parkinson; MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's

• Registration Number: EUCTR2009-011541-24-ES
• Lead Sponsor: Teva Pharmaceutical Industries Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-26
• Study Completion: 2013-02-28
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

1)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

1)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