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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Teva Neuroscience, Inc.

H. Lundbeck A/S

Information provided by (Responsible Party):

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00936676

First received: July 8, 2009

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2009

Last Updated Date

March 19, 2013

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The main outcome analysis will be of the emergence of the following milestones per subject report: Unsteady gait and balance, Falls, Freezing of gait, Cognitive decline. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00936676 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Additional analyses will assess the emergence of other PD milestones, as well as the following scales: UPDRS, UPDRS Version 4 Part 1 (EDL scale), Hoehn & Yahr, Parkinson Fatigue Scale, MoCA Scale, NMSQ, TFC, PDQ8, EQ-5D [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is:

To investigate whether the effect of early-start rasagiline treatment (according to the ADAGIO study protocol) provided long-term benefits over delayed-start.
To investigate the long-term effects of rasagiline in Parkinson's Disease (PD) subjects who participated in the ADAGIO study and have continued on rasagiline treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: rasagiline mesylate

tablets, 1mg, once daily for 24 months

Study Arm (s)

Experimental: 1

tablets, 1mg, once daily for 24 months

Intervention: Drug: rasagiline mesylate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

684

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00936676

Other Study ID Numbers ^ICMJE

TVP-1012/501, 2009-011541-24

Has Data Monitoring Committee

Responsible Party

Teva Pharmaceutical Industries

Study Sponsor ^ICMJE

Teva Pharmaceutical Industries

Collaborators ^ICMJE

Teva Neuroscience, Inc.
H. Lundbeck A/S

Investigators ^ICMJE

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

Information Provided By

Teva Pharmaceutical Industries

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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