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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:
Teva Pharmaceutical Industries
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
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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:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Rasagiline mesylate
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- 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
| 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 |
| Sexes Eligible for Study: | All |
| 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:
- 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
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
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 ( EudraCT Number ) |
| Study First Received: | July 8, 2009 |
| Last Updated: | April 8, 2016 |
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 21, 2017