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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727139
• Other study ID #: Rasagiline-5001
• Secondary ID: JapicCTI-184181
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Patients with Parkinson's disease should be surveyed.

Exclusion Criteria:

-Participants who have contraindications on package insert of rasagiline.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline
Rasagiline Tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)

External Links

•   To obtain more information on the study, click here/on this link