Recruiting NCT07629115
A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Parkinson's Disease. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Safety Evaluation: Incidence of serious adverse events of special interest [Time frame: Baseline to 5 years]
- Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs) [Time frame: Baseline to 5 years]
- Safety Evaluation: Number of participants with clinically-relevant changes in physical exams [Time frame: Baseline to 5 years]
- Safety Evaluation: Number of participants with clinically-relevant changes in laboratory test [Time frame: Baseline to 5 years]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Severance Hospital — Seoul
Identifiers
NCT: NCT07629115 · IPS101A-10-LT-01