Clinical trial NCT00936676: ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: parkinson's
long-term effects
adagio
rasagiline
delayed start
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Teva Neuroscience, Inc.
name: H. Lundbeck A/S
First posted: 2009-07-10
Enrollment: 684
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: PD Functional Status Questionnaire
timeFrame: 36 months
measure: UPDRS scores
timeFrame: 36 months
measure: EDL scale
timeFrame: 36 months
measure: Hoehn and Yahr scale
timeFrame: 36 months
measure: Parkinson's Fatigue Scale
timeFrame: 36 months
measure: Montreal Cognitive Assessment (MoCA) Scale
timeFrame: 36 months
measure: Non-motor symptom questionnaire of the PD Society
timeFrame: 36 months
measure: Quality of Life Questionnaire
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 7054
state: Alabama
city: Tucson
country: United States
facility: Teva Investigational Site 7006
state: Arizona
city: Irvine
country: United States
facility: Teva Investigational Site 7018
state: California
city: La Jolla
country: United States
facility: Teva Investigational Site 7019
state: California
city: Loma Linda
country: United States
facility: Teva Investigational Site 7039
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 7023
state: California
city: Sunnyvale
country: United States
facility: Teva Investigational Site 7022
state: California
city: Danbury
country: United States
facility: Teva Investigational Site 7024
state: Connecticut
city: Farmington
country: United States
facility: Teva Investigational Site 7016
state: Connecticut
city: Boca Raton
country: United States
facility: Teva Investigational Site 7020
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 7011
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 7045
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 7017
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 7055
state: Georgia
city: Augusta
country: United States
facility: Teva Investigational Site 7043
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 7013
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 7052
state: Illinois
city: Northbrook
country: United States
facility: Teva Investigational Site 7001
state: Illinois
city: Springfield
country: United States
facility: Teva Investigational Site 7008
state: Illinois
city: Des Moines
country: United States
facility: Teva Investigational Site 7037
state: Iowa
city: Scarborough
country: United States
facility: Teva Investigational Site 7053
state: Maine
city: Boston
country: United States
facility: Teva Investigational Site 7026
state: Massachusetts
city: Lansing
country: United States
facility: Teva Investigational Site 7015
state: Michigan
city: Traverse City
country: United States
facility: Teva Investigational Site 7010
state: Michigan
city: Golden Valley
country: United States
facility: Teva Investigational Site 7029
state: Minnesota
city: Omaha
country: United States
facility: Teva Investigational Site 7004
state: Nebraska
city: Buffalo
country: United States
facility: Teva Investigational Site 7046
state: New York
city: Durham
country: United States
facility: Teva Investigational Site 7048
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 7051
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 7034
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 7009
state: Ohio
city: Allentown
country: United States
facility: Teva Investigational Site 7002
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 7044
state: Pennsylvania
city: Providence
country: United States
facility: Teva Investigational Site 7050
state: Rhode Island
city: Houston
country: United States
facility: Teva Investigational Site 7035
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 7056
state: Texas
city: Milwaukee
country: United States
facility: Teva Investigational Site 7025
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 7160
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 7161
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 7162
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 7163
city: Pilar - Buenos Aires
country: Argentina
facility: Teva Investigational Site 7164
city: Calgary
country: Canada
facility: Teva Investigational Site 7088
state: Alberta
city: Winnipeg
country: Canada
facility: Teva Investigational Site 7086
state: Manitoba
city: Halifax
country: Canada
facility: Teva Investigational Site 7085
state: Nova Scotia
city: London
country: Canada
facility: Teva Investigational Site 7083
state: Ontario
city: Markham
country: Canada
facility: Teva Investigational Site 7087
state: Ontario
city: Toronto
country: Canada
facility: Teva Investigational Site 7089
state: Ontario
city: Montreal
country: Canada
facility: Teva Investigational Site 7081
state: Quebec
city: Québec
country: Canada
facility: Teva Investigational Site 7080
state: Quebec
city: Saskatoon
country: Canada
facility: Teva Investigational Site 7082
state: Saskatchewan
city: Aix-en-Provence
country: France
facility: Teva Investigational Site 7201
city: Clermont-Ferrand Cedex 1
country: France
facility: Teva Investigational Site 7202
city: Creteil Cedex
country: France
facility: Teva Investigational Site 7203
city: Lille Cedex
country: France
facility: Teva Investigational Site 7204
city: Nantes Cedex 1
country: France
facility: Teva Investigational Site 7206
city: Pessac
country: France
facility: Teva Investigational Site 7205
city: Toulouse Cedex 9
country: France
facility: Teva Investigational Site 7200
city: Bochum
country: Germany
facility: Teva Investigational Site 7304
city: Duesseldorf
country: Germany
facility: Teva Investigational Site 7309
city: Erbach
country: Germany
facility: Teva Investigational Site 7306
city: Gera
country: Germany
facility: Teva Investigational Site 7303
city: Kassel
country: Germany
facility: Teva Investigational Site 7307
city: Kiel
country: Germany
facility: Teva Investigational Site 7300
city: Tuebingen
country: Germany
facility: Teva Investigational Site 7308
city: Ulm
country: Germany
facility: Teva Investigational Site 7302
city: Budapest
country: Hungary
facility: Teva Investigational Site 7400
city: Budapest
country: Hungary
facility: Teva Investigational Site 7401
city: Debrecen
country: Hungary
facility: Teva Investigational Site 7404
city: Ramat -Gan
country: Israel
facility: Teva Investigational Site 7501
state: IL
city: Beer-Sheva
country: Israel
facility: Teva Investigational Site 7502
city: Haifa
country: Israel
facility: Teva Investigational Site 7504
city: Haifa
country: Israel
facility: Teva Investigational Site 7507
city: Jerusalem
country: Israel
facility: Teva Investigational Site 7505
city: Petach-Tikva
country: Israel
facility: Teva Investigational Site 7506
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 7503
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 7500
city: Grosseto
country: Italy
facility: Teva Investigational Site 7604
city: Lido di Camaiore (Lucca)
country: Italy
facility: Teva Investigational Site 7600
city: Milano
country: Italy
facility: Teva Investigational Site 7602
city: Milano
country: Italy
facility: Teva Investigational Site 7607
city: Parma
country: Italy
facility: Teva Investigational Site 7610
city: Pozzilli (IS)
country: Italy
facility: Teva Investigational Site 7601
city: Roma
country: Italy
facility: Teva Investigational Site 7606
city: Roma
country: Italy
facility: Teva Investigational Site 7611
city: Roma
country: Italy
facility: Teva Investigational Site 7615
city: Blaricum
country: Netherlands
facility: Teva Investigational Site 7704
city: Lisbon
country: Portugal
facility: Teva Investigational Site 7150
city: Bucuresti
country: Romania
facility: Teva Investigational Site 7100
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 7102
city: Constanta
country: Romania
facility: Teva Investigational Site 7104
city: Targu-Mures
country: Romania
facility: Teva Investigational Site 7103
city: Timisoara
country: Romania
facility: Teva Investigational Site 7101
city: Barcelona
country: Spain
facility: Teva Investigational Site 7800
city: Barcelona
country: Spain
facility: Teva Investigational Site 7801
city: Barcelona
country: Spain
facility: Teva Investigational Site 7802
city: Bilbao
country: Spain
facility: Teva Investigational Site 7806
city: L'Hospitalet de Llobregat
country: Spain
facility: Teva Investigational Site 7804
city: Madrid
country: Spain
facility: Teva Investigational Site 7805
city: San Sebastian
country: Spain
facility: Teva Investigational Site 7803
city: Cambridge
country: United Kingdom
facility: Teva Investigational Site 7902
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Teva Investigational Site 7900
Study officials:
affiliation: Department of Neurology, Mount Sinai School of Medicine
name: C Warren Olanow, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Pharmacology, Faculty of Medicine, University Hospital, Toulouse, France
name: Olivier Rascol, MD
role: PRINCIPAL_INVESTIGATOR
References: