Reduce medication resistant motor symptoms
- 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
- Reduce medication resistant motor symptoms
- 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 help people with very advanced Parkinson's, whose symptoms stay uncontrolled despite all available medicines, by testing whether a gene therapy can safely improve motor function and reduce medication-resistant problems. IPS101A uses an adeno-associated virus to deliver a gene into brain cells so they can produce a protein or enzyme that boosts or normalizes local dopamine signaling, which may change how levodopa works or reduce the need for higher doses, and effects and safety will be closely monitored. The early phase, dose-escalation study plans to enroll up to six people aged 50 to 80 who have had Parkinson's for at least 10 years, are Hoehn and Yahr stage 4 or 5 off meds, and whose symptoms remain uncontrolled; people with Parkinson's disease dementia, major visual hallucinations, parkinsonism-plus syndromes, 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 help people with very advanced Parkinson's, whose symptoms stay uncontrolled despite all available medicines, by testing whether a gene therapy can safely improve motor function and reduce medication-resistant problems. IPS101A uses an adeno-associated virus to deliver a gene into brain cells so they can produce a protein or enzyme that boosts or normalizes local dopamine signaling, which may change how levodopa works or reduce the need for higher doses, and effects and safety will be closely monitored. The early phase, dose-escalation study plans to enroll up to six people aged 50 to 80 who have had Parkinson's for at least 10 years, are Hoehn and Yahr stage 4 or 5 off meds, and whose symptoms remain uncontrolled; people with Parkinson's disease dementia, major visual hallucinations, parkinsonism-plus syndromes, 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.