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

June 1, 2026 updated by: Innopeutics Corporation

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

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
The group that received IPS101A
The group of subjects who received IPS101A in the IPS101A-10 clinical trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation: Incidence of serious adverse events of special interest
Time Frame: Baseline to 5 years
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)
Time Frame: Baseline to 5 years
Assess severity and frequency of reported adverse events
Baseline to 5 years
Safety Evaluation: Number of participants with clinically-relevant changes in physical exams
Time Frame: Baseline to 5 years
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
Time Frame: Baseline to 5 years
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 Outcome Measures

Outcome Measure
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)
Time Frame: Baseline to 5 years
Each symptom is rated on a scale of 0 to 4, with higher scores indicating more severe Parkinson's disease.
Baseline to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innopeutics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

September 30, 2031

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPS101A-10-LT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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