Parkinson's DiseaseNCT00936676
ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
An observational study of Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 102 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- rasagiline mesylate
- Type of treatment
- Pill or oral medicine
- How many people
- 684 participants
- Where
- 102 sitesin 13 countries
- Study dates
- Jul 2009to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
102 sites in 13 countries.
102 sites in 13 countries
United States37 sites
Teva Investigational Site 7002
Allentown, Pennsylvania
Teva Investigational Site 7055
Atlanta, Georgia
Teva Investigational Site 7043
Augusta, Georgia
Teva Investigational Site 7054
Birmingham, Alabama
Teva Investigational Site 7020
Boca Raton, Florida
Teva Investigational Site 7026
Boston, Massachusetts
Teva Investigational Site 7046
Buffalo, New York
Teva Investigational Site 7013
Chicago, Illinois
Teva Investigational Site 7052
Chicago, Illinois
Teva Investigational Site 7034
Cincinnati, Ohio
Teva Investigational Site 7024
Danbury, Connecticut
Teva Investigational Site 7037
Des Moines, Iowa
Teva Investigational Site 7048
Durham, North Carolina
Teva Investigational Site 7016
Farmington, Connecticut
Teva Investigational Site 7011
Gainesville, Florida
Teva Investigational Site 7029
Golden Valley, Minnesota
Teva Investigational Site 7035
Houston, Texas
Teva Investigational Site 7056
Houston, Texas
Teva Investigational Site 7018
Irvine, California
Teva Investigational Site 7019
La Jolla, California
Teva Investigational Site 7015
Lansing, Michigan
Teva Investigational Site 7039
Loma Linda, California
Teva Investigational Site 7023
Los Angeles, California
Teva Investigational Site 7045
Miami, Florida
Teva Investigational Site 7025
Milwaukee, Wisconsin
Teva Investigational Site 7001
Northbrook, Illinois
Teva Investigational Site 7004
Omaha, Nebraska
Teva Investigational Site 7044
Philadelphia, Pennsylvania
Teva Investigational Site 7050
Providence, Rhode Island
Teva Investigational Site 7051
Raleigh, North Carolina
Teva Investigational Site 7053
Scarborough, Maine
Teva Investigational Site 7008
Springfield, Illinois
Teva Investigational Site 7022
Sunnyvale, California
Teva Investigational Site 7017
Tampa, Florida
Teva Investigational Site 7009
Toledo, Ohio
Teva Investigational Site 7010
Traverse City, Michigan
Teva Investigational Site 7006
Tucson, Arizona
Canada9 sites
Teva Investigational Site 7088
Calgary, Alberta
Teva Investigational Site 7085
Halifax, Nova Scotia
Teva Investigational Site 7083
London, Ontario
Teva Investigational Site 7087
Markham, Ontario
Teva Investigational Site 7081
Montreal, Quebec
Teva Investigational Site 7080
Québec, Quebec
Teva Investigational Site 7082
Saskatoon, Saskatchewan
Teva Investigational Site 7089
Toronto, Ontario
Teva Investigational Site 7086
Winnipeg, Manitoba
Italy9 sites
Teva Investigational Site 7604
Grosseto
Teva Investigational Site 7600
Lido Di Camaiore (Lucca)
Teva Investigational Site 7602
Milan
Teva Investigational Site 7607
Milan
Teva Investigational Site 7610
Parma
Teva Investigational Site 7601
Pozzilli (IS)
Teva Investigational Site 7606
Roma
Teva Investigational Site 7611
Roma
Teva Investigational Site 7615
Roma
Germany8 sites
Teva Investigational Site 7304
Bochum
Teva Investigational Site 7309
Düsseldorf
Teva Investigational Site 7306
Erbach im Odenwald
Teva Investigational Site 7303
Gera
Teva Investigational Site 7307
Kassel
Teva Investigational Site 7300
Kiel
Teva Investigational Site 7308
Tübingen
Teva Investigational Site 7302
Ulm
Israel8 sites
Teva Investigational Site 7502
Beersheba
Teva Investigational Site 7504
Haifa
Teva Investigational Site 7507
Haifa
Teva Investigational Site 7505
Jerusalem
Teva Investigational Site 7506
Petah Tikva
Teva Investigational Site 7501
Ramat Gan, IL
Teva Investigational Site 7503
Ramat Gan
Teva Investigational Site 7500
Tel Aviv
France7 sites
Teva Investigational Site 7201
Aix-en-Provence
Teva Investigational Site 7202
Clermont-Ferrand
Teva Investigational Site 7203
Créteil
Teva Investigational Site 7204
Lille
Teva Investigational Site 7206
Nantes
Teva Investigational Site 7205
Pessac
Teva Investigational Site 7200
Toulouse
Spain7 sites
Teva Investigational Site 7800
Barcelona
Teva Investigational Site 7801
Barcelona
Teva Investigational Site 7802
Barcelona
Teva Investigational Site 7806
Bilbao
Teva Investigational Site 7803
Donostia / San Sebastian
Teva Investigational Site 7804
L'Hospitalet de Llobregat
Teva Investigational Site 7805
Madrid
Argentina5 sites
Teva Investigational Site 7160
Buenos Aires
Teva Investigational Site 7161
Buenos Aires
Teva Investigational Site 7162
Buenos Aires
Teva Investigational Site 7163
Buenos Aires
Teva Investigational Site 7164
Pilar - Buenos Aires
Romania5 sites
Teva Investigational Site 7100
Bucharest
Teva Investigational Site 7102
Cluj-Napoca
Teva Investigational Site 7104
Constanța
Teva Investigational Site 7103
Târgu Mureş
Teva Investigational Site 7101
Timișoara
Hungary3 sites
Teva Investigational Site 7400
Budapest
Teva Investigational Site 7401
Budapest
Teva Investigational Site 7404
Debrecen
United Kingdom2 sites
Teva Investigational Site 7902
Cambridge
Teva Investigational Site 7900
Newcastle upon Tyne
About this study
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
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).
- Conditions
- Parkinson's Disease
- Being tested
- rasagiline mesylate
- Keywords
- parkinson's, long-term effects, adagio, rasagiline, delayed start
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rasagiline mesylateDrug
Also called Azilect
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.
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline mesylate | Enrollment by invitation to participates from the ADAGIO trial Receives: Drug: rasagiline mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 36 months
EDL scale
Measured: 36 months
Hoehn and Yahr scale
0 indicates asymptomatic to 5 which indicates wheelchair bound
Measured: 36 months
Parkinson's Fatigue Scale
1 indicates strongly disagree to 5 which indicates strongly agree
Measured: 36 months
Montreal Cognitive Assessment (MoCA) Scale
assessment of mild cognitive deficits
Measured: 36 months
Non-motor symptom questionnaire of the PD Society
Yes/No questions
Measured: 36 months
Quality of Life Questionnaire
Qualitative questions using Never to Always answers
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Neuroscience, Inc., H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- C Warren Olanow, MD, FRCPC, Principal investigator, Department of Neurology, Mount Sinai School of MedicineOlivier Rascol, MD, Principal investigator, Department of Clinical Pharmacology, Faculty of Medicine, University Hospital, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936676
- Sponsor's protocol ID
- TVP-1012/501
- Other IDs
- 2009-011541-24, 2009
- Status last verified
- Apr 2016
- First submitted
- 8 Jul 2009
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00936676
- Acronym / sponsor ID
- TVP-1012/501
- Conditions
- Parkinson's Disease
- Keywords
- parkinson's, long-term effects, adagio, rasagiline, delayed start
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teva Neuroscience, Inc., H. Lundbeck A/S
- Study start
- Jul 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rasagiline mesylate | – | Drug: rasagiline mesylateEnrollment by invitation to participates from the ADAGIO trial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rasagiline mesylateAlso: AzilectDuring 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. | Drug | Rasagiline mesylate |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C Warren Olanow, MD, FRCPC principal investigator
Department of Neurology, Mount Sinai School of Medicine
Olivier Rascol, MD principal investigator
Department of Clinical Pharmacology, Faculty of Medicine, University Hospital, Toulouse, France
102 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 102 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Canada, Italy, Germany, Israel and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD Functional Status Questionnaire (time frame: 36 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.