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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

ConditionParkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-70
SponsorAnhui Provincial Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 -

Disqualifiers

None

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Observational

    Other intervention

    Long-term observational

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: