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

December 1, 2025 updated by: Anhui Provincial Hospital
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with mid-to-late stage Parkinson's disease

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat
Other: Observational
Long-term observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
52 weeks after core-shell injection

Secondary Outcome Measures

Outcome Measure
Time Frame
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
52 weeks after core-shell injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Investigators

  • Principal Investigator: Chaoshi Niu, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

December 14, 2029

Study Completion (Estimated)

December 14, 2029

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGL-193-LTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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