A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorInnopeutics Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Subject with advanced Parkinson's disease who received IPS101A gene therapy in the Phase 1 clinical trial (IPS101A-10)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6 Participants
are grouped into 1 trial groupGroup A: The group that received IPS101A
Trial outcomes
Primary outcomes
1
Safety Evaluation: Incidence of serious adverse events of special interest
Assess severity and frequency serious adverse events of special interest
Time frame
Baseline to 5 years2
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 years3
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 years4
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 yearsSecondary 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)
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 yearsSponsors and contacts
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Source ClinicalTrials.gov