A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07629115

Enrollment

Registered

2026-06-05

Start date

2026-05-29

Completion date

2031-10-30

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Parkinson's Disease

Keywords

Adeno-associated Virus, Gene therapy, AAV

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety Evaluation: Incidence of serious adverse events of special interest	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)	Baseline to 5 years	Assess severity and frequency of reported adverse events
Safety Evaluation: Number of participants with clinically-relevant changes in physical exams	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	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.

Secondary

Measure	Time frame	Description
Change from Baseline in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores (defined on/off)	Baseline to 5 years	Each symptom is rated on a scale of 0 to 4, with higher scores indicating more severe Parkinson's disease.

Countries

South Korea

Contacts

CONTACTChoLong Park

clpark@innopeutics.com+82-2-3499-4266

CONTACTTae-gyun Kim

contact@innopeutics.com

Outcome results