NCT00936676

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 684 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	rasagiline mesylate	During the Core follow-up study period, subjects will continue to receive 1 mg rasagiline once a day. During the Extended follow-up study period, only subjects who are still on rasagiline at Visit 9 will continue to receive treatment with rasagiline 1 mg per day. Tablets will be supplied by the Sponsor and given according to the label.

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-07-10
• Last updated: 2016-04-11

Locations

102 sites across 13 countries: United States, Argentina, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Romania, Spain, United Kingdom