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Completed

NCT Number: NCT03727139

Rasagiline 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients with Parkinson's disease should be surveyed.

Exclusion criteria

-Participants who have contraindications on package insert of rasagiline.

Treatment and study plan

Rasagiline

Drug

Rasagiline Tablets

Other names: AZILECT Tablets ("AZILECT" is a registered trademark of Teva Pharmaceutical Industries Ltd.)

Primary outcomes

  1. Number of Participants Who Had One or More Adverse Events

    Time frame: 24 months

    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.

  2. Number of Participants Who Had One or More Adverse Drug Reactions

    Time frame: 24 months

    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.

Secondary outcomes

  1. Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: Baseline, Up to Month 24 (Final Assessment Point)

    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).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2018
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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