Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"

AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Rasagiline

Detailed Description

The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease.

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.

• Study Type: Observational
• Enrollment (Actual): 1021

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Parkinson's disease treated with Rasagiline 1 mg tablets as part of routine medical care.

Description

Inclusion Criteria:

-Patients with Parkinson's disease should be surveyed.

Exclusion Criteria:

-Participants who have contraindications on package insert of rasagiline.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rasagiline 1 mg; Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.	Drug: Rasagiline; Rasagiline Tablets; Other Names: AZILECT Tablets ("AZILECT" is a registered trademark of Teva Pharmaceutical Industries Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)	UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome).	Baseline, Up to Month 24 (Final Assessment Point)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: Rasagiline-5001; JapicCTI-184181 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No