Parkinson Disease study: IPS101A
Official title Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
ClinicalTrials.gov ID: NCT07371338
What this study is testing
What is IPS101A?
IPS101A is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the dose-related safety and tolerability 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 monotherapy and combination therapy options. In addition, the study aims to assess the maximum tolerated dose (MTD) of IPS101A, as well as its preliminary efficacy and pharmacokinetic (PK) characteristics.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- people who have a diagnosis of Parkinson's disease that meets the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria at the time...
- Male or female people aged 50 to 80 years (inclusive) at the time of providing written informed consent, with a documented diagnosis of Parkinson's...
- people with a duration of Parkinson's disease of at least 10 years prior to the Screening Visit, based on medical history and/or medical records.
- people with Parkinson's disease that is inadequately controlled despite all available standard-of-care treatments, including monotherapy or...
- people with a Hoehn \& Yahr stage of 4 or 5 in the off state at the Screening Visit.
You likely can't join if
- people with Parkinson's disease dementia (PDD) who meet the diagnostic criteria established by the Movement Disorder Society (MDS) Task Force, as...
- people with a Korean Mini-Mental State Examination (K-MMSE) score ≤ 24 at the Screening assessment.
- people in whom imaging findings suggestive of Parkinsonism-plus syndrome are observed on PET and MRI performed at the Screening Visit, as assessed by...
- people who do not meet the diagnostic criteria for Parkinson's disease dementia but present with major visual hallucinations, as judged by the...
- people with drug-induced parkinsonism, confirmed by clinical history and/or medical records, and determined by the Investigator.
- people who are judged by the investigator to be unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seoul, South Korea. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.