RecruitingEarly Phase 1NCT06195124

A Study on the Safety and Tolerability of RGL-193 in Patients With Advanced Parkinson's Disease

A Study on the Safety and Tolerability of RGL-193 Injection in Patients With Advanced Parkinson's Disease - An Open-label and Dose-escalation Clinical Trial


Sponsor

Second Affiliated Hospital of Soochow University

Enrollment

8 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A safety study in patients with Parkinson's disease.


Eligibility

Min Age: 45 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and tolerability of RGL-193, an experimental treatment, in people with advanced Parkinson's disease who have significant motor fluctuations — meaning their medication wears off during the day and causes periods of poor movement control. **You may be eligible if...** - You are between 45 and 70 years old - You have a confirmed Parkinson's disease diagnosis with at least 5 years of disease history - You are currently on levodopa (a standard Parkinson's medication) and clearly responding to it - You experience at least 3 hours per day of "off" time when your medication isn't working well - Your Parkinson's is at a moderate-to-advanced stage (Hoehn & Yahr stage ≥ 3) - Your motor symptoms are confirmed by a movement disorder evaluation (MDS-UPDRS part III score ≥ 30 in the off state) **You may NOT be eligible if...** - You have had deep brain stimulation or other brain surgery - Your symptoms have been unstable or your medications have changed in the last month - You have significant depression, dementia, or other neurological conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRGL-193(low-dose)

Each side of the putamen received 150 μL of RGL-193, with a unilateral dose of 1.5×10\^11 VG and a bilateral dose of 3.0×10\^11 VG.

DRUGRGL-193(high-dose)

Each side of the putamen received 200 μL of RGL-193, with a unilateral dose of 5.0×10\^11 VG and a bilateral dose of 1.0×10\^12 VG.


Locations(1)

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06195124


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