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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011541-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Teva Neuroscience, Inc. | INDUSTRY |
| H. Lundbeck A/S | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline mesylate | Enrollment by invitation to participates from the ADAGIO trial |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasagiline mesylate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PD Functional Status Questionnaire | 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 | 36 months |
| UPDRS scores | 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). | 36 months |
| EDL scale | 36 months | |
| Hoehn and Yahr scale | 0 indicates asymptomatic to 5 which indicates wheelchair bound | 36 months |
| Parkinson's Fatigue Scale | 1 indicates strongly disagree to 5 which indicates strongly agree | 36 months |
| Montreal Cognitive Assessment (MoCA) Scale | assessment of mild cognitive deficits | 36 months |
| Non-motor symptom questionnaire of the PD Society | Yes/No questions |
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Inclusion Criteria:
Exclusion Criteria:
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Only those who participated in the ADAGIO trial, and who sign an approved informed consent form, will be included in the follow-up study
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 7054 | Birmingham | Alabama | United States | |||
| Teva Investigational Site 7006 |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
|
| 36 months |
| Quality of Life Questionnaire | Qualitative questions using Never to Always answers | 36 months |
| Tucson |
| Arizona |
| United States |
| Teva Investigational Site 7018 | Irvine | California | United States |
| Teva Investigational Site 7019 | La Jolla | California | United States |
| Teva Investigational Site 7039 | Loma Linda | California | United States |
| Teva Investigational Site 7023 | Los Angeles | California | United States |
| Teva Investigational Site 7022 | Sunnyvale | California | United States |
| Teva Investigational Site 7024 | Danbury | Connecticut | United States |
| Teva Investigational Site 7016 | Farmington | Connecticut | United States |
| Teva Investigational Site 7020 | Boca Raton | Florida | United States |
| Teva Investigational Site 7011 | Gainesville | Florida | United States |
| Teva Investigational Site 7045 | Miami | Florida | United States |
| Teva Investigational Site 7017 | Tampa | Florida | United States |
| Teva Investigational Site 7055 | Atlanta | Georgia | United States |
| Teva Investigational Site 7043 | Augusta | Georgia | United States |
| Teva Investigational Site 7013 | Chicago | Illinois | United States |
| Teva Investigational Site 7052 | Chicago | Illinois | United States |
| Teva Investigational Site 7001 | Northbrook | Illinois | United States |
| Teva Investigational Site 7008 | Springfield | Illinois | United States |
| Teva Investigational Site 7037 | Des Moines | Iowa | United States |
| Teva Investigational Site 7053 | Scarborough | Maine | United States |
| Teva Investigational Site 7026 | Boston | Massachusetts | United States |
| Teva Investigational Site 7015 | Lansing | Michigan | United States |
| Teva Investigational Site 7010 | Traverse City | Michigan | United States |
| Teva Investigational Site 7029 | Golden Valley | Minnesota | United States |
| Teva Investigational Site 7004 | Omaha | Nebraska | United States |
| Teva Investigational Site 7046 | Buffalo | New York | United States |
| Teva Investigational Site 7048 | Durham | North Carolina | United States |
| Teva Investigational Site 7051 | Raleigh | North Carolina | United States |
| Teva Investigational Site 7034 | Cincinnati | Ohio | United States |
| Teva Investigational Site 7009 | Toledo | Ohio | United States |
| Teva Investigational Site 7002 | Allentown | Pennsylvania | United States |
| Teva Investigational Site 7044 | Philadelphia | Pennsylvania | United States |
| Teva Investigational Site 7050 | Providence | Rhode Island | United States |
| Teva Investigational Site 7035 | Houston | Texas | United States |
| Teva Investigational Site 7056 | Houston | Texas | United States |
| Teva Investigational Site 7025 | Milwaukee | Wisconsin | United States |
| Teva Investigational Site 7160 | Buenos Aires | Argentina |
| Teva Investigational Site 7161 | Buenos Aires | Argentina |
| Teva Investigational Site 7162 | Buenos Aires | Argentina |
| Teva Investigational Site 7163 | Buenos Aires | Argentina |
| Teva Investigational Site 7164 | Pilar - Buenos Aires | Argentina |
| Teva Investigational Site 7088 | Calgary | Alberta | Canada |
| Teva Investigational Site 7086 | Winnipeg | Manitoba | Canada |
| Teva Investigational Site 7085 | Halifax | Nova Scotia | Canada |
| Teva Investigational Site 7083 | London | Ontario | Canada |
| Teva Investigational Site 7087 | Markham | Ontario | Canada |
| Teva Investigational Site 7089 | Toronto | Ontario | Canada |
| Teva Investigational Site 7081 | Montreal | Quebec | Canada |
| Teva Investigational Site 7080 | Québec | Quebec | Canada |
| Teva Investigational Site 7082 | Saskatoon | Saskatchewan | Canada |
| Teva Investigational Site 7201 | Aix-en-Provence | France |
| Teva Investigational Site 7202 | Clermont-Ferrand | France |
| Teva Investigational Site 7203 | Créteil | France |
| Teva Investigational Site 7204 | Lille | France |
| Teva Investigational Site 7206 | Nantes | France |
| Teva Investigational Site 7205 | Pessac | France |
| Teva Investigational Site 7200 | Toulouse | France |
| Teva Investigational Site 7304 | Bochum | Germany |
| Teva Investigational Site 7309 | Düsseldorf | Germany |
| Teva Investigational Site 7306 | Erbach im Odenwald | Germany |
| Teva Investigational Site 7303 | Gera | Germany |
| Teva Investigational Site 7307 | Kassel | Germany |
| Teva Investigational Site 7300 | Kiel | Germany |
| Teva Investigational Site 7308 | Tübingen | Germany |
| Teva Investigational Site 7302 | Ulm | Germany |
| Teva Investigational Site 7400 | Budapest | Hungary |
| Teva Investigational Site 7401 | Budapest | Hungary |
| Teva Investigational Site 7404 | Debrecen | Hungary |
| Teva Investigational Site 7501 | Ramat Gan | IL | Israel |
| Teva Investigational Site 7502 | Beersheba | Israel |
| Teva Investigational Site 7504 | Haifa | Israel |
| Teva Investigational Site 7507 | Haifa | Israel |
| Teva Investigational Site 7505 | Jerusalem | Israel |
| Teva Investigational Site 7506 | Petah Tikva | Israel |
| Teva Investigational Site 7503 | Ramat Gan | Israel |
| Teva Investigational Site 7500 | Tel Aviv | Israel |
| Teva Investigational Site 7604 | Grosseto | Italy |
| Teva Investigational Site 7600 | Lido Di Camaiore (Lucca) | Italy |
| Teva Investigational Site 7602 | Milan | Italy |
| Teva Investigational Site 7607 | Milan | Italy |
| Teva Investigational Site 7610 | Parma | Italy |
| Teva Investigational Site 7601 | Pozzilli (IS) | Italy |
| Teva Investigational Site 7606 | Roma | Italy |
| Teva Investigational Site 7611 | Roma | Italy |
| Teva Investigational Site 7615 | Roma | Italy |
| Teva Investigational Site 7704 | Blaricum | Netherlands |
| Teva Investigational Site 7150 | Lisbon | Portugal |
| Teva Investigational Site 7100 | Bucharest | Romania |
| Teva Investigational Site 7102 | Cluj-Napoca | Romania |
| Teva Investigational Site 7104 | Constanța | Romania |
| Teva Investigational Site 7103 | Târgu Mureş | Romania |
| Teva Investigational Site 7101 | Timișoara | Romania |
| Teva Investigational Site 7800 | Barcelona | Spain |
| Teva Investigational Site 7801 | Barcelona | Spain |
| Teva Investigational Site 7802 | Barcelona | Spain |
| Teva Investigational Site 7806 | Bilbao | Spain |
| Teva Investigational Site 7803 | Donostia / San Sebastian | Spain |
| Teva Investigational Site 7804 | L'Hospitalet de Llobregat | Spain |
| Teva Investigational Site 7805 | Madrid | Spain |
| Teva Investigational Site 7902 | Cambridge | United Kingdom |
| Teva Investigational Site 7900 | Newcastle upon Tyne | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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