ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects - Full Text View

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 Perry syndrome

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Hoehn and Yahr scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
0 indicates asymptomatic to 5 which indicates wheelchair bound
Parkinson's Fatigue Scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
1 indicates strongly disagree to 5 which indicates strongly agree
Montreal Cognitive Assessment (MoCA) Scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
assessment of mild cognitive deficits
Non-motor symptom questionnaire of the PD Society [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Yes/No questions
Quality of Life Questionnaire [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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
Genders Eligible for Study:	Both
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

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:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00936676 History of Changes
Other Study ID Numbers:	TVP-1012/501 2009-011541-24
Study First Received:	July 8, 2009
Last Updated:	April 8, 2016
Health Authority:	United States: Institutional Review Board

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 26, 2016