Parkinson's DiseaseNCT07279844
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
An observational study of Parkinson's Disease, run by Anhui Provincial Hospital.
Trial summary
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Observational
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 14 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mid-to-late stage Parkinson's disease
Who may be able to join
- 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 -
Who cannot join
- None
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years
Read the 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
- Conditions
- Parkinson's Disease
- Being tested
- Observational
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Long-term observational
| Study group | Role | What they receive |
|---|---|---|
| Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years
Measured: 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.
Measured: 52 weeks after core-shell injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion14 Dec 2029 (estimated)
- Study completion14 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chaoshi Niu, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279844
- Sponsor's protocol ID
- RGL-193-LTS
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07279844
- Acronym / sponsor ID
- RGL-193-LTS
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 14 Dec 2029 (estimated)
- Study completion
- 14 Dec 2029 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat | – | Other: Observational |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mid-to-late stage Parkinson's disease
Key inclusion criteria (2 listed)
- 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 -
Key exclusion criteria (2 listed)
- None
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalLong-term observational | Other | Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treat |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chaoshi Niu principal investigator
The First Affiliated Hospital of University of Science and Technology of China
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaoshi Niu (+86 13855186208, niuchaoshi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.