Parkinson DiseaseNCT07629115
A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
An observational study of Parkinson Disease and Parkinson's Disease, run by Innopeutics Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Parkinson's Disease
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2026to 30 Oct 2031
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with advanced Parkinson's disease who received IPS101A gene therapy in the Phase 1 clinical trial (IPS101A-10)
Who may be able to join
- Subjects who were enrolled in the IPS101A-10 clinical trial and received IPS101A.
- Subjects and/or their legally acceptable representatives who voluntarily provided written informed consent to participate in this long-term follow-up study after being fully informed of the study, and who agreed to comply with all study-related requirements.
Who cannot join
- Subjects who decline to provide consent for participation in the long-term follow-up study, or for whom follow-up assessments are not feasible due to death or other reasons.
- Subjects who, in the judgment of the investigator, are considered unsuitable for participation in the study due to unwillingness or inability to comply with scheduled study visits or other study-related requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tae-gyun Kim contact
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
Professor, MD, PhD, phlee@yuhs.ac
About this study
Official title: A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product in the IPS101A-10 Phase I Clinical Trial
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A.
- Conditions
- Parkinson Disease, Parkinson's Disease
- Keywords
- Adeno-associated Virus, Gene therapy, AAV
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The group that received IPS101A | The group of subjects who received IPS101A in the IPS101A-10 clinical trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation: Incidence of serious adverse events of special interest
Assess severity and frequency serious adverse events of special interest
Measured: Baseline to 5 years
Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs)
Assess severity and frequency of reported adverse events
Measured: Baseline to 5 years
Safety Evaluation: Number of participants with clinically-relevant changes in physical exams
The results of the physical examination after administration of the clinical trial drug are compared with those before administration to determine whether clinically significant symptoms occur
Measured: Baseline to 5 years
Safety Evaluation: Number of participants with clinically-relevant changes in laboratory test
The clinical significance of laboratory test results after administration of a clinical trial drug is confirmed by comparing them with those before administration.
Measured: Baseline to 5 years
Secondary outcomes (1)
Change from Baseline in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores (defined on/off)
Each symptom is rated on a scale of 0 to 4, with higher scores indicating more severe Parkinson's disease.
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start29 May 2026
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innopeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629115
- Sponsor's protocol ID
- IPS101A-10-LT-01
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product in the IPS101A-10 Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT07629115
- Acronym / sponsor ID
- IPS101A-10-LT-01
- Conditions
- Parkinson Disease, Parkinson's Disease
- Keywords
- Adeno-associated Virus, Gene therapy, AAV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Innopeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 5 Jun 2026 (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.
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The group that received IPS101A | – | –The group of subjects who received IPS101A in the IPS101A-10 clinical trial |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with advanced Parkinson's disease who received IPS101A gene therapy in the Phase 1 clinical trial (IPS101A-10)
Key inclusion criteria (2 listed)
- Subjects who were enrolled in the IPS101A-10 clinical trial and received IPS101A.
- Subjects and/or their legally acceptable representatives who voluntarily provided written informed consent to participate in this long-term follow-up study after being fully informed of the study, and who agreed to comply with all study-related requirements.
Key exclusion criteria (2 listed)
- Subjects who decline to provide consent for participation in the long-term follow-up study, or for whom follow-up assessments are not feasible due to death or other reasons.
- Subjects who, in the judgment of the investigator, are considered unsuitable for participation in the study due to unwillingness or inability to comply with scheduled study visits or other study-related requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety Evaluation: Incidence of serious adverse events of special interest
Time frame: Baseline to 5 years
Assess severity and frequency serious adverse events of special interest
Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs)
Time frame: Baseline to 5 years
Assess severity and frequency of reported adverse events
Safety Evaluation: Number of participants with clinically-relevant changes in physical exams
Time frame: Baseline to 5 years
The results of the physical examination after administration of the clinical trial drug are compared with those before administration to determine whether clinically significant symptoms occur
Safety Evaluation: Number of participants with clinically-relevant changes in laboratory test
Time frame: Baseline to 5 years
The clinical significance of laboratory test results after administration of a clinical trial drug is confirmed by comparing them with those before administration.
1 secondary outcome
Change from Baseline in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores (defined on/off)
Time frame: Baseline to 5 years
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Tae-gyun Kim contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinson's Disease, run by Innopeutics Corporation at 1 site in South Korea.
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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 ChoLong Park (+82-2-3499-4266, clpark@innopeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation: Incidence of serious adverse events of special interest (time frame: Baseline to 5 years). The study lists 4 primary outcomes in all. 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 1 Jul 2026.