This study wants to measure the dose-related whether it is safe and how hard side effects are to live with of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available this drug alone and combination therapy options. In addition, the study aims to assess the maximum tolerated dose (MTD) of IPS101A, as well as its preliminary how well it works and pharmacokinetic (PK) characteristics.
Official registry: https://clinicaltrials.gov/study/NCT07371338 · Innopeutics Corporation · enrollment listed as 6
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are IPS101A. The registry lists allocation as randomized. This study wants to measure the dose-related whether it is safe and how hard side effects are to live with of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available this drug alone and combination therapy options.
They plan to enroll about 6 people at Seoul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: IPS101A
Primary outcome (registry wording): Safety Evaluation: dose-limiting toxicity (DLT)
ChoLong Park
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment.
NCT00060541 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest.
NCT01581580 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern.
NCT04375280 · Official ClinicalTrials.gov record · University Hospital, Clermont-Ferrand
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary