An Open-label, Observational, Long-term Follow-up Study Evaluating the Safety and Efficacy of RGL-193 Putamen Injection in Patients With Primary Parkinson's Disease

To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years

Not Yet Recruiting

Trial opening soon.

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

An open-label, observational, long-term follow-up study evaluating the safety and efficacy of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treatment；
Those who voluntarily participate in this trial and sign a written informed consent form -

Exclusion criteria

None

Treatment and study plan

Observational

Other

Long-term observational

Primary outcomes

To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years

Time frame: 52 weeks after core-shell injection

Secondary outcomes

Assess the metabolic activity of related enzymes in patients with primary PD over 5 years following RGL-193 capsid injection.

Time frame: 52 weeks after core-shell injection

Study contacts

Contact information is provided by the study sponsor or research team.

Chaoshi Niu

CONTACT

[email protected]

+86 13855186208

Chi Xiong

CONTACT

[email protected]

+86 18709857411

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Dec 12, 2025
Registry last updated: Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting