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 Type
OBSERVATIONAL
Enrollment
6
Severance Hospital
Seoul, South Korea
RECRUITINGSafety Evaluation: Incidence of serious adverse events of special interest
Assess severity and frequency serious adverse events of special interest
Time frame: Baseline to 5 years
Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs)
Assess severity and frequency of reported adverse events
Time frame: 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
Time frame: 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.
Time frame: Baseline to 5 years
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.
Time frame: Baseline to 5 years
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