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

NCT00936676 | Completed

• 2 other identifiers: TVP-1012/5012009-011541-24
• Study Type: observational
• Target: 684
• Locations: 13 countries
• Sites: 102

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).

Conditions

Parkinson's Disease

Keywords

parkinson's; long-term effects; adagio; rasagiline; delayed start

Outcome Measures

Primary Outcomes (8)

• 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

  36 months

• Quality of Life Questionnaire

  Qualitative questions using Never to Always answers

  36 months

Study Arms (1)

Rasagiline mesylate

Enrollment by invitation to participates from the ADAGIO trial

Drug: rasagiline mesylate

Interventions

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.

Also known as: Azilect

Rasagiline mesylate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
• Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• Teva Neuroscience, Inc.: collaborator
• H. Lundbeck A/S: collaborator

Study Sites (102)

Teva Investigational Site 7054

Birmingham, Alabama, United States

Location

Teva Investigational Site 7006

Tucson, Arizona, United States

Location

Teva Investigational Site 7018

Irvine, California, United States

Location

Teva Investigational Site 7019

La Jolla, California, United States

Location

Teva Investigational Site 7039

Loma Linda, California, United States

Location

Teva Investigational Site 7023

Los Angeles, California, United States

Location

Teva Investigational Site 7022

Sunnyvale, California, United States

Location

Teva Investigational Site 7024

Danbury, Connecticut, United States

Location

Teva Investigational Site 7016

Farmington, Connecticut, United States

Location

Teva Investigational Site 7020

Boca Raton, Florida, United States

Location

Teva Investigational Site 7011

Gainesville, Florida, United States

Location

Teva Investigational Site 7045

Miami, Florida, United States

Location

Teva Investigational Site 7017

Tampa, Florida, United States

Location

Teva Investigational Site 7055

Atlanta, Georgia, United States

Location

Teva Investigational Site 7043

Augusta, Georgia, United States

Location

Teva Investigational Site 7013

Chicago, Illinois, United States

Location

Teva Investigational Site 7052

Chicago, Illinois, United States

Location

Teva Investigational Site 7001

Northbrook, Illinois, United States

Location

Teva Investigational Site 7008

Springfield, Illinois, United States

Location

Teva Investigational Site 7037

Des Moines, Iowa, United States

Location

Teva Investigational Site 7053

Scarborough, Maine, United States

Location

Teva Investigational Site 7026

Boston, Massachusetts, United States

Location

Teva Investigational Site 7015

Lansing, Michigan, United States

Location

Teva Investigational Site 7010

Traverse City, Michigan, United States

Location

Teva Investigational Site 7029

Golden Valley, Minnesota, United States

Location

Teva Investigational Site 7004

Omaha, Nebraska, United States

Location

Teva Investigational Site 7046

Buffalo, New York, United States

Location

Teva Investigational Site 7048

Durham, North Carolina, United States

Location

Teva Investigational Site 7051

Raleigh, North Carolina, United States

Location

Teva Investigational Site 7034

Cincinnati, Ohio, United States

Location

Teva Investigational Site 7009

Toledo, Ohio, United States

Location

Teva Investigational Site 7002

Allentown, Pennsylvania, United States

Location

Teva Investigational Site 7044

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 7050

Providence, Rhode Island, United States

Location

Teva Investigational Site 7035

Houston, Texas, United States

Location

Teva Investigational Site 7056

Houston, Texas, United States

Location

Teva Investigational Site 7025

Milwaukee, Wisconsin, United States

Location

Teva Investigational Site 7160

Buenos Aires, Argentina

Location

Teva Investigational Site 7161

Buenos Aires, Argentina

Location

Teva Investigational Site 7162

Buenos Aires, Argentina

Location

Teva Investigational Site 7163

Buenos Aires, Argentina

Location

Teva Investigational Site 7164

Pilar - Buenos Aires, Argentina

Location

Teva Investigational Site 7088

Calgary, Alberta, Canada

Location

Teva Investigational Site 7086

Winnipeg, Manitoba, Canada

Location

Teva Investigational Site 7085

Halifax, Nova Scotia, Canada

Location

Teva Investigational Site 7083

London, Ontario, Canada

Location

Teva Investigational Site 7087

Markham, Ontario, Canada

Location

Teva Investigational Site 7089

Toronto, Ontario, Canada

Location

Teva Investigational Site 7081

Montreal, Quebec, Canada

Location

Teva Investigational Site 7080

Québec, Quebec, Canada

Location

Teva Investigational Site 7082

Saskatoon, Saskatchewan, Canada

Location

Teva Investigational Site 7201

Aix-en-Provence, France

Location

Teva Investigational Site 7202

Clermont-Ferrand, France

Location

Teva Investigational Site 7203

Créteil, France

Location

Teva Investigational Site 7204

Lille, France

Location

Teva Investigational Site 7206

Nantes, France

Location

Teva Investigational Site 7205

Pessac, France

Location

Teva Investigational Site 7200

Toulouse, France

Location

Teva Investigational Site 7304

Bochum, Germany

Location

Teva Investigational Site 7309

Düsseldorf, Germany

Location

Teva Investigational Site 7306

Erbach im Odenwald, Germany

Location

Teva Investigational Site 7303

Gera, Germany

Location

Teva Investigational Site 7307

Kassel, Germany

Location

Teva Investigational Site 7300

Kiel, Germany

Location

Teva Investigational Site 7308

Tübingen, Germany

Location

Teva Investigational Site 7302

Ulm, Germany

Location

Teva Investigational Site 7400

Budapest, Hungary

Location

Teva Investigational Site 7401

Budapest, Hungary

Location

Teva Investigational Site 7404

Debrecen, Hungary

Location

Teva Investigational Site 7501

Ramat Gan, IL, Israel

Location

Teva Investigational Site 7502

Beersheba, Israel

Location

Teva Investigational Site 7504

Haifa, Israel

Location

Teva Investigational Site 7507

Haifa, Israel

Location

Teva Investigational Site 7505

Jerusalem, Israel

Location

Teva Investigational Site 7506

Petah Tikva, Israel

Location

Teva Investigational Site 7503

Ramat Gan, Israel

Location

Teva Investigational Site 7500

Tel Aviv, Israel

Location

Teva Investigational Site 7604

Grosseto, Italy

Location

Teva Investigational Site 7600

Lido Di Camaiore (Lucca), Italy

Location

Teva Investigational Site 7602

Milan, Italy

Location

Teva Investigational Site 7607

Milan, Italy

Location

Teva Investigational Site 7610

Parma, Italy

Location

Teva Investigational Site 7601

Pozzilli (IS), Italy

Location

Teva Investigational Site 7606

Roma, Italy

Location

Teva Investigational Site 7611

Roma, Italy

Location

Teva Investigational Site 7615

Roma, Italy

Location

Teva Investigational Site 7704

Blaricum, Netherlands

Location

Teva Investigational Site 7150

Lisbon, Portugal

Location

Teva Investigational Site 7100

Bucharest, Romania

Location

Teva Investigational Site 7102

Cluj-Napoca, Romania

Location

Teva Investigational Site 7104

Constanța, Romania

Location

Teva Investigational Site 7103

Târgu Mureş, Romania

Location

Teva Investigational Site 7101

Timișoara, Romania

Location

Teva Investigational Site 7800

Barcelona, Spain

Location

Teva Investigational Site 7801

Barcelona, Spain

Location

Teva Investigational Site 7802

Barcelona, Spain

Location

Teva Investigational Site 7806

Bilbao, Spain

Location

Teva Investigational Site 7803

Donostia / San Sebastian, Spain

Location

Teva Investigational Site 7804

L'Hospitalet de Llobregat, Spain

Location

Teva Investigational Site 7805

Madrid, Spain

Location

Teva Investigational Site 7902

Cambridge, United Kingdom

Location

Teva Investigational Site 7900

Newcastle upon Tyne, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

NL (1); CA (9); HU (3); RO (5); FR (7); PT (1); DE (8); IL (8); IT (9); US (37); AR (5); ES (7); GB (2)