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

April 8, 2016 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Teva Investigational Site 7160
      • Buenos Aires, Argentina
        • Teva Investigational Site 7161
      • Buenos Aires, Argentina
        • Teva Investigational Site 7162
      • Buenos Aires, Argentina
        • Teva Investigational Site 7163
      • Pilar - Buenos Aires, Argentina
        • Teva Investigational Site 7164
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Teva Investigational Site 7088
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Teva Investigational Site 7086
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Teva Investigational Site 7085
    • Ontario
      • London, Ontario, Canada
        • Teva Investigational Site 7083
      • Markham, Ontario, Canada
        • Teva Investigational Site 7087
      • Toronto, Ontario, Canada
        • Teva Investigational Site 7089
    • Quebec
      • Montreal, Quebec, Canada
        • Teva Investigational Site 7081
      • Québec, Quebec, Canada
        • Teva Investigational Site 7080
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Teva Investigational Site 7082
  • France
      • Aix-en-Provence, France
        • Teva Investigational Site 7201
      • Clermont-Ferrand Cedex 1, France
        • Teva Investigational Site 7202
      • Creteil Cedex, France
        • Teva Investigational Site 7203
      • Lille Cedex, France
        • Teva Investigational Site 7204
      • Nantes Cedex 1, France
        • Teva Investigational Site 7206
      • Pessac, France
        • Teva Investigational Site 7205
      • Toulouse Cedex 9, France
        • Teva Investigational Site 7200
  • Germany
      • Bochum, Germany
        • Teva Investigational Site 7304
      • Duesseldorf, Germany
        • Teva Investigational Site 7309
      • Erbach, Germany
        • Teva Investigational Site 7306
      • Gera, Germany
        • Teva Investigational Site 7303
      • Kassel, Germany
        • Teva Investigational Site 7307
      • Kiel, Germany
        • Teva Investigational Site 7300
      • Tuebingen, Germany
        • Teva Investigational Site 7308
      • Ulm, Germany
        • Teva Investigational Site 7302
  • Hungary
      • Budapest, Hungary
        • Teva Investigational Site 7400
      • Budapest, Hungary
        • Teva Investigational Site 7401
      • Debrecen, Hungary
        • Teva Investigational Site 7404
  • Israel
      • Beer-Sheva, Israel
        • Teva Investigational Site 7502
      • Haifa, Israel
        • Teva Investigational Site 7504
      • Haifa, Israel
        • Teva Investigational Site 7507
      • Jerusalem, Israel
        • Teva Investigational Site 7505
      • Petach-Tikva, Israel
        • Teva Investigational Site 7506
      • Ramat Gan, Israel
        • Teva Investigational Site 7503
      • Tel Aviv, Israel
        • Teva Investigational Site 7500
    • IL
      • Ramat -Gan, IL, Israel
        • Teva Investigational Site 7501
  • Italy
      • Grosseto, Italy
        • Teva Investigational Site 7604
      • Lido di Camaiore (Lucca), Italy
        • Teva Investigational Site 7600
      • Milano, Italy
        • Teva Investigational Site 7602
      • Milano, Italy
        • Teva Investigational Site 7607
      • Parma, Italy
        • Teva Investigational Site 7610
      • Pozzilli (IS), Italy
        • Teva Investigational Site 7601
      • Roma, Italy
        • Teva Investigational Site 7606
      • Roma, Italy
        • Teva Investigational Site 7611
      • Roma, Italy
        • Teva Investigational Site 7615
  • Netherlands
      • Blaricum, Netherlands
        • Teva Investigational Site 7704
  • Portugal
      • Lisbon, Portugal
        • Teva Investigational Site 7150
  • Romania
      • Bucuresti, Romania
        • Teva Investigational Site 7100
      • Cluj-Napoca, Romania
        • Teva Investigational Site 7102
      • Constanta, Romania
        • Teva Investigational Site 7104
      • Targu-Mures, Romania
        • Teva Investigational Site 7103
      • Timisoara, Romania
        • Teva Investigational Site 7101
  • Spain
      • Barcelona, Spain
        • Teva Investigational Site 7800
      • Barcelona, Spain
        • Teva Investigational Site 7801
      • Barcelona, Spain
        • Teva Investigational Site 7802
      • Bilbao, Spain
        • Teva Investigational Site 7806
      • L'Hospitalet de Llobregat, Spain
        • Teva Investigational Site 7804
      • Madrid, Spain
        • Teva Investigational Site 7805
      • San Sebastian, Spain
        • Teva Investigational Site 7803
  • United Kingdom
      • Cambridge, United Kingdom
        • Teva Investigational Site 7902
      • Newcastle-Upon-Tyne, United Kingdom
        • Teva Investigational Site 7900
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Teva Investigational Site 7054
    • Arizona
      • Tucson, Arizona, United States
        • Teva Investigational Site 7006
    • California
      • Irvine, California, United States
        • Teva Investigational Site 7018
      • La Jolla, California, United States
        • Teva Investigational Site 7019
      • Loma Linda, California, United States
        • Teva Investigational Site 7039
      • Los Angeles, California, United States
        • Teva Investigational Site 7023
      • Sunnyvale, California, United States
        • Teva Investigational Site 7022
    • Connecticut
      • Danbury, Connecticut, United States
        • Teva Investigational Site 7024
      • Farmington, Connecticut, United States
        • Teva Investigational Site 7016
    • Florida
      • Boca Raton, Florida, United States
        • Teva Investigational Site 7020
      • Gainesville, Florida, United States
        • Teva Investigational Site 7011
      • Miami, Florida, United States
        • Teva Investigational Site 7045
      • Tampa, Florida, United States
        • Teva Investigational Site 7017
    • Georgia
      • Atlanta, Georgia, United States
        • Teva Investigational Site 7055
      • Augusta, Georgia, United States
        • Teva Investigational Site 7043
    • Illinois
      • Chicago, Illinois, United States
        • Teva Investigational Site 7013
      • Chicago, Illinois, United States
        • Teva Investigational Site 7052
      • Northbrook, Illinois, United States
        • Teva Investigational Site 7001
      • Springfield, Illinois, United States
        • Teva Investigational Site 7008
    • Iowa
      • Des Moines, Iowa, United States
        • Teva Investigational Site 7037
    • Maine
      • Scarborough, Maine, United States
        • Teva Investigational Site 7053
    • Massachusetts
      • Boston, Massachusetts, United States
        • Teva Investigational Site 7026
    • Michigan
      • Lansing, Michigan, United States
        • Teva Investigational Site 7015
      • Traverse City, Michigan, United States
        • Teva Investigational Site 7010
    • Minnesota
      • Golden Valley, Minnesota, United States
        • Teva Investigational Site 7029
    • Nebraska
      • Omaha, Nebraska, United States
        • Teva Investigational Site 7004
    • New York
      • Buffalo, New York, United States
        • Teva Investigational Site 7046
    • North Carolina
      • Durham, North Carolina, United States
        • Teva Investigational Site 7048
      • Raleigh, North Carolina, United States
        • Teva Investigational Site 7051
    • Ohio
      • Cincinnati, Ohio, United States
        • Teva Investigational Site 7034
      • Toledo, Ohio, United States
        • Teva Investigational Site 7009
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Teva Investigational Site 7002
      • Philadelphia, Pennsylvania, United States
        • Teva Investigational Site 7044
    • Rhode Island
      • Providence, Rhode Island, United States
        • Teva Investigational Site 7050
    • Texas
      • Houston, Texas, United States
        • Teva Investigational Site 7035
      • Houston, Texas, United States
        • Teva Investigational Site 7056
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Teva Investigational Site 7025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Azilect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months
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).
36 months
EDL scale
Time Frame: 36 months
36 months
Hoehn and Yahr scale
Time Frame: 36 months
0 indicates asymptomatic to 5 which indicates wheelchair bound
36 months
Parkinson's Fatigue Scale
Time Frame: 36 months
1 indicates strongly disagree to 5 which indicates strongly agree
36 months
Montreal Cognitive Assessment (MoCA) Scale
Time Frame: 36 months
assessment of mild cognitive deficits
36 months
Non-motor symptom questionnaire of the PD Society
Time Frame: 36 months
Yes/No questions
36 months
Quality of Life Questionnaire
Time Frame: 36 months
Qualitative questions using Never to Always answers
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

H. Lundbeck A/S
Teva Neuroscience, Inc.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (ESTIMATE)

July 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVP-1012/501
  • 2009-011541-24 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on rasagiline mesylate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe