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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Teva Neuroscience, Inc.
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00936676
First received: July 8, 2009
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is:

  • To investigate whether the effect of early-start rasagiline treatment (according to the ADAGIO study protocol) provided long-term benefits over delayed-start.
  • To investigate the long-term effects of rasagiline in Parkinson's Disease (PD) subjects who participated in the ADAGIO study and have continued on rasagiline treatment.

Condition Intervention Phase
Parkinson's Disease
 Drug: rasagiline mesylate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The main outcome analysis will be of the emergence of the following milestones per subject report: Unsteady gait and balance, Falls, Freezing of gait, Cognitive decline. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional analyses will assess the emergence of other PD milestones, as well as the following scales: UPDRS, UPDRS Version 4 Part 1 (EDL scale), Hoehn & Yahr, Parkinson Fatigue Scale, MoCA Scale, NMSQ, TFC, PDQ8, EQ-5D [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 684
Study Start Date: July 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
tablets, 1mg, once daily for 24 months
 Drug: rasagiline mesylate
tablets, 1mg, once daily for 24 months

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936676

  Show 102 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Teva Neuroscience, Inc.
H. Lundbeck A/S
Investigators
Principal Investigator: C Warren Olanow, MD, FRCPC Department of Neurology, Mount Sinai School of Medicine
Principal Investigator: Olivier Rascol, MD Department of Clinical Pharmacology, Faculty of Medicine, University Hospital, Toulouse, France
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00936676     History of Changes
Other Study ID Numbers: TVP-1012/501, 2009-011541-24
Study First Received: July 8, 2009
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
parkinson's
long-term effects
adagio
rasagiline
delayed start

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
 Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013