ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects

Completed

Conditions studied: Parkinson's Disease

In brief

Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).

Key facts

Study ID

NCT00936676

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

684

Starts

2009-07-01

Expected to finish

2013-03-01

Last updated by the study team

2016-04-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who participated in the ADAGIO study, and who entered the active phase of the study and
• 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
• Subjects with a diagnosis of Parkinson's disease and
• Subjects willing and able to give written informed consent

You may not qualify if…

• Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
• 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
• Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation

Where it is running

• Teva Investigational Site 7006 — Tucson, Arizona, United States
• Teva Investigational Site 7018 — Irvine, California, United States
• Teva Investigational Site 7019 — La Jolla, California, United States
• Teva Investigational Site 7039 — Loma Linda, California, United States
• Teva Investigational Site 7023 — Los Angeles, California, United States
• Teva Investigational Site 7022 — Sunnyvale, California, United States
• Teva Investigational Site 7024 — Danbury, Connecticut, United States
• Teva Investigational Site 7016 — Farmington, Connecticut, United States
• Teva Investigational Site 7020 — Boca Raton, Florida, United States
• Teva Investigational Site 7011 — Gainesville, Florida, United States
• Teva Investigational Site 7045 — Miami, Florida, United States
• Teva Investigational Site 7017 — Tampa, Florida, United States
• Teva Investigational Site 7055 — Atlanta, Georgia, United States
• Teva Investigational Site 7043 — Augusta, Georgia, United States
• Teva Investigational Site 7013 — Chicago, Illinois, United States
• Teva Investigational Site 7052 — Chicago, Illinois, United States
• Teva Investigational Site 7001 — Northbrook, Illinois, United States
• Teva Investigational Site 7008 — Springfield, Illinois, United States
• Teva Investigational Site 7037 — Des Moines, Iowa, United States
• Teva Investigational Site 7053 — Scarborough, Maine, United States
• Teva Investigational Site 7026 — Boston, Massachusetts, United States
• Teva Investigational Site 7015 — Lansing, Michigan, United States
• Teva Investigational Site 7010 — Traverse City, Michigan, United States
• Teva Investigational Site 7029 — Golden Valley, Minnesota, United States
• Teva Investigational Site 7054 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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