Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease

NCT04691661 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-16

No results posted yet for this study

Summary

This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease

Conditions

  • Parkinson Disease

Interventions

DRUG

Radotinib HCl 50 mg

Enrolled subject will continue to administer Radotinib 50mg/day, 100mg/day, 150mg/day, 200mg/day, depending on the dose level once daily for 6 months.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Il-Yang Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Philippe DAMIER, Pr. · CHU Nantes - Hôpital Nord Guillaume et René Laennec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04691661 on ClinicalTrials.gov