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

NCT07629115 | Recruiting

• 1 other identifier: IPS101A-10-LT-01
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Parkinson's Disease

Keywords

Adeno-associated Virus; Gene therapy; AAV

Outcome Measures

Primary Outcomes (4)

• Safety Evaluation: Incidence of serious adverse events of special interest

  Assess severity and frequency serious adverse events of special interest

  Baseline to 5 years

• Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs)

  Assess severity and frequency of reported adverse events

  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

  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.

  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)

  Baseline to 5 years

Study Arms (1)

The group that received IPS101A

The group of subjects who received IPS101A in the IPS101A-10 clinical trial

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with advanced Parkinson's disease who received IPS101A gene therapy in the Phase 1 clinical trial (IPS101A-10)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innopeutics Corporation: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

ChoLong Park

CONTACT

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

Tae-gyun Kim

CONTACT

contact@innopeutics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 5, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): July 30, 2031
• Study Completion (Estimated): October 30, 2031
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)