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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07279844

Enrollment

Registered

2025-12-12

Start date

2025-12-15

Completion date

2029-12-14

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

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

Detailed description

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

Interventions

OTHERObservational

Long-term observational

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

45 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treatment； 2. Those who voluntarily participate in this trial and sign a written informed consent form -

Exclusion criteria

None \-

Design outcomes

Primary

Measure	Time frame
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years	52 weeks after core-shell injection

Secondary

Measure	Time frame
Assess the metabolic activity of related enzymes in patients with primary PD over 5 years following RGL-193 capsid injection.	52 weeks after core-shell injection

Contacts

Primary ContactChaoshi Niu

niuchaoshi@163.com+86 13855186208

Backup ContactChi Xiong

xiongchi@ustc.edu.cn+86 18709857411

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026