Not yet recruiting NCT07279844
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: 45 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Observational
Long-term observational
Primary outcome measures
- 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 outcome measures (1)
- 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]
Eligibility criteria
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07279844 · RGL-193-LTS