Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-31

Brief Summary

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To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).

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Detailed Description

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Conditions

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REM Sleep Behavior Disorder Parkinson Disease Synucleinopathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Early Intervention

0-52 week: rasagiline 1 mg/day

Group Type EXPERIMENTAL

Rasagiline

Intervention Type DRUG

1 mg rasagiline

Delayed Intervention

0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day

Group Type ACTIVE_COMPARATOR

Rasagiline

Intervention Type DRUG

1 mg rasagiline

Interventions

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Rasagiline

1 mg rasagiline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline)
* no clinical diagnosis of Parkinson's disease or dementia at baseline
* age 30-75
* no concomitant or previous use of any other anti-parkinson medications
* provide written informed consent

Exclusion Criteria

* diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic)
* secondary RBD (eg., drug-induced, immune-mediated)
* nervous system comorbidities (eg., stroke, epilepsy, encephalitis)
* severe psychiatric comorbidities
* allergic to rasagiline
* severe systemic diseases (eg., end-stage kidney disease, liver failure)

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No