Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
2 other identifiers
observational
1,021
1 country
1
Brief Summary
The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedResults Posted
Study results publicly available
March 8, 2024
CompletedMarch 8, 2024
September 1, 2023
3 years
October 30, 2018
October 23, 2022
September 1, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Had One or More Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
24 months
Number of Participants Who Had One or More Adverse Drug Reactions
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
24 months
Secondary Outcomes (1)
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)
Baseline, Up to Month 24 (Final Assessment Point)
Study Arms (1)
Rasagiline 1 mg
Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Interventions
Rasagiline Tablets
Eligibility Criteria
Patients with Parkinson's disease treated with Rasagiline 1 mg tablets as part of routine medical care.
You may qualify if:
- Patients with Parkinson's disease should be surveyed.
You may not qualify if:
- Participants who have contraindications on package insert of rasagiline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda Selected Site
Tokyo, Japan
Related Publications (1)
Hattori N, Kajita M, Fujimoto S, Izutsu M, Fernandez J. Safety and effectiveness of rasagiline in patients with Parkinson's disease in Japan: a post-marketing surveillance study. Expert Opin Drug Saf. 2024 Jan;23(1):79-88. doi: 10.1080/14740338.2023.2293207. Epub 2023 Dec 20.
PMID: 38124528DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 1, 2018
Study Start
November 1, 2018
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
March 8, 2024
Results First Posted
March 8, 2024
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.