ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
- Registration Number
- NCT00936676
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 684
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rasagiline mesylate rasagiline mesylate Enrollment by invitation to participates from the ADAGIO trial
- Primary Outcome Measures
Name Time Method Hoehn and Yahr scale 36 months 0 indicates asymptomatic to 5 which indicates wheelchair bound
Parkinson's Fatigue Scale 36 months 1 indicates strongly disagree to 5 which indicates strongly agree
PD Functional Status Questionnaire 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 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 36 months Montreal Cognitive Assessment (MoCA) Scale 36 months assessment of mild cognitive deficits
Non-motor symptom questionnaire of the PD Society 36 months Yes/No questions
Quality of Life Questionnaire 36 months Qualitative questions using Never to Always answers
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (102)
Teva Investigational Site 7002
🇺🇸Allentown, Pennsylvania, United States
Teva Investigational Site 7020
🇺🇸Boca Raton, Florida, United States
Teva Investigational Site 7016
🇺🇸Farmington, Connecticut, United States
Teva Investigational Site 7023
🇺🇸Los Angeles, California, United States
Teva Investigational Site 7055
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 7006
🇺🇸Tucson, Arizona, United States
Teva Investigational Site 7024
🇺🇸Danbury, Connecticut, United States
Teva Investigational Site 7601
🇮🇹Pozzilli (IS), Italy
Teva Investigational Site 7160
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 7039
🇺🇸Loma Linda, California, United States
Teva Investigational Site 7019
🇺🇸La Jolla, California, United States
Teva Investigational Site 7206
🇫🇷Nantes Cedex 1, France
Teva Investigational Site 7505
🇮🇱Jerusalem, Israel
Teva Investigational Site 7008
🇺🇸Springfield, Illinois, United States
Teva Investigational Site 7009
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 7306
🇩🇪Erbach, Germany
Teva Investigational Site 7602
🇮🇹Milano, Italy
Teva Investigational Site 7615
🇮🇹Roma, Italy
Teva Investigational Site 7303
🇩🇪Gera, Germany
Teva Investigational Site 7201
🇫🇷Aix-en-Provence, France
Teva Investigational Site 7029
🇺🇸Golden Valley, Minnesota, United States
Teva Investigational Site 7801
🇪🇸Barcelona, Spain
Teva Investigational Site 7805
🇪🇸Madrid, Spain
Teva Investigational Site 7803
🇪🇸San Sebastian, Spain
Teva Investigational Site 7308
🇩🇪Tuebingen, Germany
Teva Investigational Site 7302
🇩🇪Ulm, Germany
Teva Investigational Site 7806
🇪🇸Bilbao, Spain
Teva Investigational Site 7053
🇺🇸Scarborough, Maine, United States
Teva Investigational Site 7600
🇮🇹Lido di Camaiore (Lucca), Italy
Teva Investigational Site 7163
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 7088
🇨🇦Calgary, Alberta, Canada
Teva Investigational Site 7010
🇺🇸Traverse City, Michigan, United States
Teva Investigational Site 7800
🇪🇸Barcelona, Spain
Teva Investigational Site 7704
🇳🇱Blaricum, Netherlands
Teva Investigational Site 7001
🇺🇸Northbrook, Illinois, United States
Teva Investigational Site 7802
🇪🇸Barcelona, Spain
Teva Investigational Site 7204
🇫🇷Lille Cedex, France
Teva Investigational Site 7304
🇩🇪Bochum, Germany
Teva Investigational Site 7900
🇬🇧Newcastle-Upon-Tyne, United Kingdom
Teva Investigational Site 7081
🇨🇦Montreal, Quebec, Canada
Teva Investigational Site 7309
🇩🇪Duesseldorf, Germany
Teva Investigational Site 7607
🇮🇹Milano, Italy
Teva Investigational Site 7086
🇨🇦Winnipeg, Manitoba, Canada
Teva Investigational Site 7502
🇮🇱Beer-Sheva, Israel
Teva Investigational Site 7051
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 7015
🇺🇸Lansing, Michigan, United States
Teva Investigational Site 7161
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 7162
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 7507
🇮🇱Haifa, Israel
Teva Investigational Site 7611
🇮🇹Roma, Italy
Teva Investigational Site 7610
🇮🇹Parma, Italy
Teva Investigational Site 7606
🇮🇹Roma, Italy
Teva Investigational Site 7203
🇫🇷Creteil Cedex, France
Teva Investigational Site 7200
🇫🇷Toulouse Cedex 9, France
Teva Investigational Site 7083
🇨🇦London, Ontario, Canada
Teva Investigational Site 7150
🇵🇹Lisbon, Portugal
Teva Investigational Site 7103
🇷🇴Targu-Mures, Romania
Teva Investigational Site 7082
🇨🇦Saskatoon, Saskatchewan, Canada
Teva Investigational Site 7100
🇷🇴Bucuresti, Romania
Teva Investigational Site 7101
🇷🇴Timisoara, Romania
Teva Investigational Site 7102
🇷🇴Cluj-Napoca, Romania
Teva Investigational Site 7018
🇺🇸Irvine, California, United States
Teva Investigational Site 7022
🇺🇸Sunnyvale, California, United States
Teva Investigational Site 7043
🇺🇸Augusta, Georgia, United States
Teva Investigational Site 7046
🇺🇸Buffalo, New York, United States
Teva Investigational Site 7164
🇦🇷Pilar - Buenos Aires, Argentina
Teva Investigational Site 7085
🇨🇦Halifax, Nova Scotia, Canada
Teva Investigational Site 7089
🇨🇦Toronto, Ontario, Canada
Teva Investigational Site 7080
🇨🇦Québec, Quebec, Canada
Teva Investigational Site 7087
🇨🇦Markham, Ontario, Canada
Teva Investigational Site 7202
🇫🇷Clermont-Ferrand Cedex 1, France
Teva Investigational Site 7205
🇫🇷Pessac, France
Teva Investigational Site 7307
🇩🇪Kassel, Germany
Teva Investigational Site 7400
🇭🇺Budapest, Hungary
Teva Investigational Site 7300
🇩🇪Kiel, Germany
Teva Investigational Site 7404
🇭🇺Debrecen, Hungary
Teva Investigational Site 7401
🇭🇺Budapest, Hungary
Teva Investigational Site 7501
🇮🇱Ramat -Gan, IL, Israel
Teva Investigational Site 7504
🇮🇱Haifa, Israel
Teva Investigational Site 7506
🇮🇱Petach-Tikva, Israel
Teva Investigational Site 7604
🇮🇹Grosseto, Italy
Teva Investigational Site 7500
🇮🇱Tel Aviv, Israel
Teva Investigational Site 7503
🇮🇱Ramat Gan, Israel
Teva Investigational Site 7104
🇷🇴Constanta, Romania
Teva Investigational Site 7804
🇪🇸L'Hospitalet de Llobregat, Spain
Teva Investigational Site 7050
🇺🇸Providence, Rhode Island, United States
Teva Investigational Site 7044
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 7902
🇬🇧Cambridge, United Kingdom
Teva Investigational Site 7045
🇺🇸Miami, Florida, United States
Teva Investigational Site 7017
🇺🇸Tampa, Florida, United States
Teva Investigational Site 7004
🇺🇸Omaha, Nebraska, United States
Teva Investigational Site 7034
🇺🇸Cincinnati, Ohio, 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 7054
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 7011
🇺🇸Gainesville, Florida, United States
Teva Investigational Site 7013
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 7052
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 7026
🇺🇸Boston, Massachusetts, United States
Teva Investigational Site 7048
🇺🇸Durham, North Carolina, United States
Teva Investigational Site 7037
🇺🇸Des Moines, Iowa, United States