Parkinson's Disease MedDRA version: 13.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: AZILECT
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline
CAS Number: 161735-79-1
Current Sponsor code: TVP-1012
Sponsors
Teva Pharmaceutical Industries Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Core Follow-Up 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 Extended Follow-Up 1) Subjects who completed the Core follow-up study period (whether they are on rasagiline treatment or not) 2) Subjects with a diagnosis of Parkinson’s disease at the Core termination visit ( Visit 9, month 24) 3) Subjects willing and able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 317 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 366
Exclusion criteria
Exclusion criteria: Core Follow-Up 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 Extended-Follow-Up 1) Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation in the extended follow-up study 2) Subjects who can no longer be given rasagiline due to any emergent exclusion based on the local label (including pregnancy or nursing women) or due to the new use of medications contraindicated for concomitant use with rasagiline according to local label (for subjects who are still on rasagiline at Visit 9)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: NA;Timepoint(s) of evaluation of this end point: NA; Main Objective: -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 PD subjects who participated in the ADAGIO study and have continued on rasagiline treatment. ; Primary end point(s): There is no primary endpoint in this study. The main outcome analysis will be of the emergence of the following milestones since the last assessment (short or long visit) per subject report: - Unsteady gait and balance - Falls - Freezing of gait - Cognitive decline (at least two positive answers for the cognitive function questions) For these outcome measures descriptive statistics will be supplied as well as Kaplan-Meier plots of time to first emergence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Argentina, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Romania, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Teva Pharma GmbH
Outcome results
None listed