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

This study has been completed.
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: May 8, 2014
Last verified: May 2014
  Purpose

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).


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Observed Benefits of rasagiline treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Observed effect of early-start rasagiline treatment provided during ADAGIO study over long-term benefits of delayed-start treatment


Enrollment: 684
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rasagiline mesylate
Enrollment by invitation to participates from the ADAGIO trial
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.
Other Name: Azilect

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Only those who participated in the ADAGIO trial, and who sign an approved informed consent form, will be included in the follow-up study

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 89 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

Additional 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: May 8, 2014
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014