NCT07279844

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
44mo left

Started Dec 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Dec 2029

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2029

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat

Other: Observational

Interventions

ObservationalOTHER

Long-term observational

Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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 -

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Vector

MeSH Terms

Conditions

Parkinson Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Chaoshi Niu

    The First Affiliated Hospital of University of Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaoshi Niu

CONTACT

+86 13855186208niuchaoshi@163.com

Chi Xiong

CONTACT

+86 18709857411xiongchi@ustc.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

December 14, 2029

Study Completion (Estimated)

December 14, 2029

Last Updated

December 12, 2025

Record last verified: 2025-12