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

NCT ID: NCT00936676

Last Updated: 2016-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

684 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rasagiline mesylate

Enrollment by invitation to participates from the ADAGIO trial

rasagiline mesylate

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Azilect

Eligibility Criteria

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Inclusion Criteria

1. Subjects who participated in the ADAGIO study, and who entered the active phase of the study and
2. 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
3. Subjects with a diagnosis of Parkinson's disease and
4. Subjects willing and able to give written informed consent

Exclusion Criteria

1. Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
2. 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
3. Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C Warren Olanow, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Mount Sinai School of Medicine

Olivier Rascol, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Faculty of Medicine, University Hospital, Toulouse, France

Locations

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Teva Investigational Site 7054

Birmingham, Alabama, United States

Site Status

Teva Investigational Site 7006

Tucson, Arizona, United States

Site Status

Teva Investigational Site 7018

Irvine, California, United States

Site Status

Teva Investigational Site 7019

La Jolla, California, United States

Site Status

Teva Investigational Site 7039

Loma Linda, California, United States

Site Status

Teva Investigational Site 7023

Los Angeles, California, United States

Site Status

Teva Investigational Site 7022

Sunnyvale, California, United States

Site Status

Teva Investigational Site 7024

Danbury, Connecticut, United States

Site Status

Teva Investigational Site 7016

Farmington, Connecticut, United States

Site Status

Teva Investigational Site 7020

Boca Raton, Florida, United States

Site Status

Teva Investigational Site 7011

Gainesville, Florida, United States

Site Status

Teva Investigational Site 7045

Miami, Florida, United States

Site Status

Teva Investigational Site 7017

Tampa, Florida, United States

Site Status

Teva Investigational Site 7055

Atlanta, Georgia, United States

Site Status

Teva Investigational Site 7043

Augusta, Georgia, United States

Site Status

Teva Investigational Site 7013

Chicago, Illinois, United States

Site Status

Teva Investigational Site 7052

Chicago, Illinois, United States

Site Status

Teva Investigational Site 7001

Northbrook, Illinois, United States

Site Status

Teva Investigational Site 7008

Springfield, Illinois, United States

Site Status

Teva Investigational Site 7037

Des Moines, Iowa, United States

Site Status

Teva Investigational Site 7053

Scarborough, Maine, United States

Site Status

Teva Investigational Site 7026

Boston, Massachusetts, United States

Site Status

Teva Investigational Site 7015

Lansing, Michigan, United States

Site Status

Teva Investigational Site 7010

Traverse City, Michigan, United States

Site Status

Teva Investigational Site 7029

Golden Valley, Minnesota, United States

Site Status

Teva Investigational Site 7004

Omaha, Nebraska, United States

Site Status

Teva Investigational Site 7046

Buffalo, New York, United States

Site Status

Teva Investigational Site 7048

Durham, North Carolina, United States

Site Status

Teva Investigational Site 7051

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 7034

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 7009

Toledo, Ohio, United States

Site Status

Teva Investigational Site 7002

Allentown, Pennsylvania, United States

Site Status

Teva Investigational Site 7044

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site 7050

Providence, Rhode Island, United States

Site Status

Teva Investigational Site 7035

Houston, Texas, United States

Site Status

Teva Investigational Site 7056

Houston, Texas, United States

Site Status

Teva Investigational Site 7025

Milwaukee, Wisconsin, United States

Site Status

Teva Investigational Site 7160

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 7161

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 7162

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 7163

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 7164

Pilar - Buenos Aires, , Argentina

Site Status

Teva Investigational Site 7088

Calgary, Alberta, Canada

Site Status

Teva Investigational Site 7086

Winnipeg, Manitoba, Canada

Site Status

Teva Investigational Site 7085

Halifax, Nova Scotia, Canada

Site Status

Teva Investigational Site 7083

London, Ontario, Canada

Site Status

Teva Investigational Site 7087

Markham, Ontario, Canada

Site Status

Teva Investigational Site 7089

Toronto, Ontario, Canada

Site Status

Teva Investigational Site 7081

Montreal, Quebec, Canada

Site Status

Teva Investigational Site 7080

Québec, Quebec, Canada

Site Status

Teva Investigational Site 7082

Saskatoon, Saskatchewan, Canada

Site Status

Teva Investigational Site 7201

Aix-en-Provence, , France

Site Status

Teva Investigational Site 7202

Clermont-Ferrand, , France

Site Status

Teva Investigational Site 7203

Créteil, , France

Site Status

Teva Investigational Site 7204

Lille, , France

Site Status

Teva Investigational Site 7206

Nantes, , France

Site Status

Teva Investigational Site 7205

Pessac, , France

Site Status

Teva Investigational Site 7200

Toulouse, , France

Site Status

Teva Investigational Site 7304

Bochum, , Germany

Site Status

Teva Investigational Site 7309

Düsseldorf, , Germany

Site Status

Teva Investigational Site 7306

Erbach im Odenwald, , Germany

Site Status

Teva Investigational Site 7303

Gera, , Germany

Site Status

Teva Investigational Site 7307

Kassel, , Germany

Site Status

Teva Investigational Site 7300

Kiel, , Germany

Site Status

Teva Investigational Site 7308

Tübingen, , Germany

Site Status

Teva Investigational Site 7302

Ulm, , Germany

Site Status

Teva Investigational Site 7400

Budapest, , Hungary

Site Status

Teva Investigational Site 7401

Budapest, , Hungary

Site Status

Teva Investigational Site 7404

Debrecen, , Hungary

Site Status

Teva Investigational Site 7501

Ramat Gan, IL, Israel

Site Status

Teva Investigational Site 7502

Beersheba, , Israel

Site Status

Teva Investigational Site 7504

Haifa, , Israel

Site Status

Teva Investigational Site 7507

Haifa, , Israel

Site Status

Teva Investigational Site 7505

Jerusalem, , Israel

Site Status

Teva Investigational Site 7506

Petah Tikva, , Israel

Site Status

Teva Investigational Site 7503

Ramat Gan, , Israel

Site Status

Teva Investigational Site 7500

Tel Aviv, , Israel

Site Status

Teva Investigational Site 7604

Grosseto, , Italy

Site Status

Teva Investigational Site 7600

Lido Di Camaiore (Lucca), , Italy

Site Status

Teva Investigational Site 7602

Milan, , Italy

Site Status

Teva Investigational Site 7607

Milan, , Italy

Site Status

Teva Investigational Site 7610

Parma, , Italy

Site Status

Teva Investigational Site 7601

Pozzilli (IS), , Italy

Site Status

Teva Investigational Site 7606

Roma, , Italy

Site Status

Teva Investigational Site 7611

Roma, , Italy

Site Status

Teva Investigational Site 7615

Roma, , Italy

Site Status

Teva Investigational Site 7704

Blaricum, , Netherlands

Site Status

Teva Investigational Site 7150

Lisbon, , Portugal

Site Status

Teva Investigational Site 7100

Bucharest, , Romania

Site Status

Teva Investigational Site 7102

Cluj-Napoca, , Romania

Site Status

Teva Investigational Site 7104

Constanța, , Romania

Site Status

Teva Investigational Site 7103

Târgu Mureş, , Romania

Site Status

Teva Investigational Site 7101

Timișoara, , Romania

Site Status

Teva Investigational Site 7800

Barcelona, , Spain

Site Status

Teva Investigational Site 7801

Barcelona, , Spain

Site Status

Teva Investigational Site 7802

Barcelona, , Spain

Site Status

Teva Investigational Site 7806

Bilbao, , Spain

Site Status

Teva Investigational Site 7803

Donostia / San Sebastian, , Spain

Site Status

Teva Investigational Site 7804

L'Hospitalet de Llobregat, , Spain

Site Status

Teva Investigational Site 7805

Madrid, , Spain

Site Status

Teva Investigational Site 7902

Cambridge, , United Kingdom

Site Status

Teva Investigational Site 7900

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Argentina Canada France Germany Hungary Israel Italy Netherlands Portugal Romania Spain United Kingdom

Related Links

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Other Identifiers

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2009-011541-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TVP-1012/501

Identifier Type: -

Identifier Source: org_study_id

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