A trial to follow-up subjects with Parkinson's disease who participated to the ADAGIO study in order to study the long-term effects of the drug rasagiline

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 13.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-29
• Study Completion: 2013-02-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

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

Inclusion Criteria

Core Follow-Up
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

Extended Follow-Up
1) Subjects who completed the Core follow-up study period (whether
they are on rasagiline treatment or not)
2) Subjects with a diagnosis of Parkinson’s disease at the Core
termination visit ( Visit 9, month 24)
3) Subjects willing and able to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 317
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 366

Exclusion Criteria

Core Follow-Up
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

Extended-Follow-Up
1) Subjects with a medical condition that is considered by the
investigator as significant enough to prevent participation in the
extended follow-up study
2) Subjects who can no longer be given rasagiline due to any
emergent exclusion based on the local label (including pregnancy
or nursing women) or due to the new use of medications
contraindicated for concomitant use with rasagiline according to
local label (for subjects who are still on rasagiline at Visit 9)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified