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

NCT00936676 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 684

Last updated 2016-04-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Teva Neuroscience, Inc.

    collaborator INDUSTRY

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • C Warren Olanow, MD, FRCPC · Department of Neurology, Mount Sinai School of Medicine

  • Olivier Rascol, MD · Department of Clinical Pharmacology, Faculty of Medicine, University Hospital, Toulouse, France

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Portugal
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936676 on ClinicalTrials.gov