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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727139
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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.

Condition or disease Intervention/treatment
Parkinson's Disease 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 Design
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Study Type : Observational
Actual Enrollment : 1021 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: AZILECT Tablets ("AZILECT" is a registered trademark of Teva Pharmaceutical Industries Ltd.)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants who Had One or More Adverse Events [ Time Frame: Month 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score [ Time Frame: Baseline, Up to Month 24 ]
    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 have 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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

-Patients with Parkinson's disease should be surveyed.

Exclusion Criteria:

-Participants who have contraindications on package insert of rasagiline.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727139


Locations
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Japan
Takeda Selected Site
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03727139    
Other Study ID Numbers: Rasagiline-5001
JapicCTI-184181 ( Registry Identifier: JapicCTI )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs