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NCT Number: NCT07629115

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson's Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Professor, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Secondary 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ChoLong Park

CONTACT

[email protected]

+82-2-3499-4266

Tae-gyun Kim

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Innopeutics Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 5, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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