ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
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ClinicalTrials.gov Identifier: NCT00936676 |
Recruitment Status :
Completed
First Posted : July 10, 2009
Last Update Posted : April 11, 2016
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Condition or disease | Intervention/treatment |
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Parkinson's Disease | Drug: rasagiline mesylate |
Study Type : | Observational |
Actual Enrollment : | 684 participants |
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 |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Group/Cohort | Intervention/treatment |
---|---|
Rasagiline mesylate
Enrollment by invitation to participates from the ADAGIO trial
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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 |
- PD Functional Status Questionnaire [ Time Frame: 36 months ]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 ]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 ]
- Hoehn and Yahr scale [ Time Frame: 36 months ]0 indicates asymptomatic to 5 which indicates wheelchair bound
- Parkinson's Fatigue Scale [ Time Frame: 36 months ]1 indicates strongly disagree to 5 which indicates strongly agree
- Montreal Cognitive Assessment (MoCA) Scale [ Time Frame: 36 months ]assessment of mild cognitive deficits
- Non-motor symptom questionnaire of the PD Society [ Time Frame: 36 months ]Yes/No questions
- Quality of Life Questionnaire [ Time Frame: 36 months ]Qualitative questions using Never to Always answers

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects who participated in the ADAGIO study, and who entered the active phase of the study and
- 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
- Subjects with a diagnosis of Parkinson's disease and
- Subjects willing and able to give written informed consent
Exclusion Criteria:
- Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
- 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
- Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936676

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 |
Responsible Party: | Teva Branded Pharmaceutical Products R&D, Inc. |
ClinicalTrials.gov Identifier: | NCT00936676 |
Other Study ID Numbers: |
TVP-1012/501 2009-011541-24 ( EudraCT Number ) |
First Posted: | July 10, 2009 Key Record Dates |
Last Update Posted: | April 11, 2016 |
Last Verified: | April 2016 |
parkinson's long-term effects adagio rasagiline delayed start |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Rasagiline Monoamine Oxidase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neuroprotective Agents Protective Agents Physiological Effects of Drugs |