IPS101A for Parkinson's (NCT07371338)
Find safe gene therapy dose
- Trial ID
- NCT07371338
- Official Title
- Dose-Escalation, Single-Center, Open-label Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Adeno-associated Virus(AAV) Gene Therapy Product IPS101A in Parkinson's Disease Patients With Hoehn-Yahr Stage 4-5, Diagnosed in More Than 10 Years and Uncontrolled by All Available Monotherapy or Combination Therapy
- Goal
- Find safe gene therapy dose
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Innopeutics Corporation
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease, Parkinson's Disease
- Interventions
- IPS101A
Summary For Families
The goal is to test different doses of a new gene therapy given with an adeno-associated virus to see how safe and tolerable it is in people with very advanced Parkinson's, to find the highest dose people can tolerate, and to collect early signs of benefit and information on how the body handles the treatment. The approach is a gene therapy product delivered using an adeno-associated virus, and the study will carefully monitor side effects, early effectiveness, and how the therapy moves through the body. They are looking for people aged 50 to 80 who have had Parkinson's for at least 10 years and who have severe disability (stage 4 or 5) not controlled by standard treatments; people with Parkinson's disease dementia, low cognitive test scores, certain scan findings suggesting other conditions, major visual hallucinations, or drug-induced parkinsonism are excluded.
Locations
- Severance Hospital, Seoul, South Korea
Frequently Asked Questions
- What is this trial testing?
- This trial is studying IPS101A. The goal is to test different doses of a new gene therapy given with an adeno-associated virus to see how safe and tolerable it is in people with very advanced Parkinson's, to find the highest dose people can tolerate, and to collect early signs of benefit and information on how the body handles the treatment. The approach is a gene therapy product delivered using an adeno-associated virus, and the study will carefully monitor side effects, early effectiveness, and how the therapy moves through the body. They are looking for people aged 50 to 80 who have had Parkinson's for at least 10 years and who have severe disability (stage 4 or 5) not controlled by standard treatments; people with Parkinson's disease dementia, low cognitive test scores, certain scan findings suggesting other conditions, major visual hallucinations, or drug-induced parkinsonism are excluded.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.