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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: April 8, 2016
Last verified: April 2016
  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
Parkinson's Disease
Drug: rasagiline mesylate

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:
  • PD Functional Status Questionnaire [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Assess Benefits of rasagiline treatment using yes/no questions; Milestones of time to treatment-Dopaminergic treatment, levodopa, surgery for PD, time to -dyskinesia, hallucinations, functional decline using an aggregate of the responses to PD Functional Status Questionnaire

  • UPDRS scores [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Part I is designed to rate mentation, behavior and mood (questions 1-4). Part II (questions 5-17) is designed to rate activities of daily life. Both parts I and II are to be collected as historical information. Part III (questions 18-31) is done as a motor examination at the time of a visit as defined in this protocol. The various items to be rated are scored using a 5-point system (i.e., 0 is normal and 4 indicates a severe abnormality, half point scores are allowed for Part III questions).

  • EDL scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Hoehn and Yahr scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    0 indicates asymptomatic to 5 which indicates wheelchair bound

  • Parkinson's Fatigue Scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    1 indicates strongly disagree to 5 which indicates strongly agree

  • Montreal Cognitive Assessment (MoCA) Scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    assessment of mild cognitive deficits

  • Non-motor symptom questionnaire of the PD Society [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Yes/No questions

  • Quality of Life Questionnaire [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Qualitative questions using Never to Always answers


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

Ages Eligible for Study:   Child, Adult, Senior
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 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

Additional Information:
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: April 8, 2016
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
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016