Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
NCT ID: NCT03727139
Last Updated: 2024-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
1021 participants
OBSERVATIONAL
2018-11-01
2021-10-31
Brief Summary
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Detailed Description
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This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000.
This multi-center observational trial will be conducted in Japan.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rasagiline 1 mg
Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Rasagiline
Rasagiline Tablets
Interventions
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Rasagiline
Rasagiline Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Takeda Selected Site
Tokyo, , Japan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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JapicCTI-184181
Identifier Type: REGISTRY
Identifier Source: secondary_id
Rasagiline-5001
Identifier Type: -
Identifier Source: org_study_id
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