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

Teva Branded Pharmaceutical Products R&D, Inc.684 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

684

Conditions

Parkinson's Disease

Interventions

rasagiline mesylateDRUG

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.

Eligibility

Medical Language ↔ Plain English

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

Locations (102)

Teva Investigational Site 7054

Birmingham, Alabama, United States

Teva Investigational Site 7006

Tucson, Arizona, United States

Teva Investigational Site 7018

Irvine, California, United States

Teva Investigational Site 7019

La Jolla, California, United States

Teva Investigational Site 7039

Loma Linda, California, United States

Outcomes

Primary Outcomes

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

Time frame: 36 months

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).

Time frame: 36 months

EDL scale

Time frame: 36 months

Hoehn and Yahr scale

0 indicates asymptomatic to 5 which indicates wheelchair bound

Time frame: 36 months

Parkinson's Fatigue Scale

1 indicates strongly disagree to 5 which indicates strongly agree

Time frame: 36 months

Montreal Cognitive Assessment (MoCA) Scale

assessment of mild cognitive deficits

Time frame: 36 months

Non-motor symptom questionnaire of the PD Society

Yes/No questions

Time frame: 36 months

Quality of Life Questionnaire

Qualitative questions using Never to Always answers

Time frame: 36 months