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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080224120

Enrollment

1021

Registered

2018-10-30

Start date

2018-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

investigational material(s) Generic name etc : Rasagiline INN of investigational material : rasagiline Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with Parkinson's disease should be surveyed.

Exclusion criteria

Exclusion criteria: - Participants who have contraindications on package insert of rasagiline.

Design outcomes

Primary

Measure	Time frame
safety Number of Participants Who Had One or More Adverse Events Timeframe; 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. safety Number of Participants Who Had One or More Adverse Drug Reactions Timeframe; 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.	—

Measure

Time frame

safety Number of Participants Who Had One or More Adverse Events Timeframe; 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. safety Number of Participants Who Had One or More Adverse Drug Reactions Timeframe; 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.

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Secondary

Measure	Time frame
efficacy Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score Timeframe; 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).	—

Measure

Time frame

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

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026