Trial intelligence / Profile preview

WIN-1001X in Early Parkinson's Disease

NCT04220762Phase 2

Key facts

Status: Unknown
Start: Jan 2020
Primary completion: Jun 2021
Countries: 1
Sponsor: Medi Help Line
Modality: Small Molecules

Drugs: WIN-1001X
Conditions: Parkinson's disease (PD)

Overview

Phase 2, randomised, double-blind trial of WIN-1001X in Parkinson's disease (PD) (4 arms), sponsored by Medi Help Line. Primary endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III at 12 weeks. Status: unknown.

Design

4 arms

Study design: RandomizedDouble-blind

WIN-1001X 400 mg
WIN-1001X 400 mg twice daily.
WIN-1001X 800 mg
WIN-1001X 800 mg twice daily.
WIN-1001X 1200 mg
WIN-1001X 1200 mg twice daily.
Placebo
Placebo twice daily.

Who it enrols

Patients aged 30 or older with early Parkinson's disease (Modified Hoehn and Yahr stage <= 3.0) and decreased dopamine transporters. Patients must not have received antiparkinsonian drugs for at least 6 months or must have a 4-week washout period.

Endpoints

Primary

Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III12 weeks

Secondary

Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III8 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part I12 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part II12 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Total Score (Part I+II+III)12 weeks
Modified Hoehn and Yahr Scale12 weeks
Korean Non-Motor Symptoms Scale12 weeks
Korean-Montreal Cognitive Assessment12 weeks
Korean Parkinson's Disease Questionnaire-3912 weeks

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