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

NCT ID: NCT07279844

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2029-12-14

Brief Summary

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

Detailed Description

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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

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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

Observational

Intervention Type OTHER

Long-term observational

Interventions

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Observational

Long-term observational

Intervention Type OTHER

Eligibility Criteria

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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

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Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chaoshi Niu

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

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Chaoshi Niu

Role: CONTACT

+86 13855186208

Chi Xiong

Role: CONTACT

+86 18709857411

Other Identifiers

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RGL-193-LTS

Identifier Type: -

Identifier Source: org_study_id

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