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

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Rasagiline

• Registration Number: NCT03727139
• Lead Sponsor: Takeda

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.

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 Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Study Start: 2018-11-01
• Study First Posted: 2018-11-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Results First Submitted: 2022-10-23
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1021

Inclusion Criteria

-Patients with Parkinson's disease should be surveyed.

Exclusion Criteria

-Participants who have contraindications on package insert of rasagiline.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rasagiline 1 mg	Rasagiline	Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had One or More Adverse Events	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.
Number of Participants Who Had One or More Adverse Drug Reactions	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 Outcome Measures

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

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan