Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The group that received IPS101A | The group of subjects who received IPS101A in the IPS101A-10 clinical trial |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 5 years |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Subject with advanced Parkinson's disease who received IPS101A gene therapy in the Phase 1 clinical trial (IPS101A-10)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChoLong Park | Contact | +82-2-3499-4266 | clpark@innopeutics.com | |
| Tae-gyun Kim | Contact | contact@innopeutics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |