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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT03727139
Collaborator
(none)
1,021
Enrollment
1
Location
36
Actual Duration (Months)
28.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase

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

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 :
Nov 1, 2018
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm 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.)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants who Had One or More Adverse Events [Month 24]

    Secondary Outcome Measures

    1. Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score [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

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -Patients with Parkinson's disease should be surveyed.

    Exclusion Criteria:

    -Participants who have contraindications on package insert of rasagiline.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takeda Selected Site Tokyo Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT03727139
    Other Study ID Numbers:
    • Rasagiline-5001
    • JapicCTI-184181
    First Posted:
    Nov 1, 2018
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Rasagiline

    Study Results

    No Results Posted as of Nov 9, 2021