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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936676
• Other study ID #: TVP-1012/501
• Secondary ID: 2009-011541-24
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: April 8, 2016
• Start date: July 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries	H. Lundbeck A/S, Teva Neuroscience, Inc.

Countries where clinical trial is conducted

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

Outcome

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

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