Study of ASP2246 Brain Infusion Surgery for Adults with Movement Problems After Stroke Phase 12 Safety and Dose Finding Trial

What this Trial Is About

Researchers are evaluating ASP2246 in adults who have movement difficulties several months after a stroke. This first-in-human study aims to assess the safety, tolerability, and appropriate dosing of ASP2246 to support future research. The trial focuses on adults with motor dysfunction caused by chronic ischemic stroke affecting a specific brain area. The study has two parts. In Part 1, participants undergo brain surgery to receive increasing doses of ASP2246 delivered slowly through a special tube directly into the damaged brain region. In Part 2, participants have similar brain surgery and receive either a higher dose, a lower dose of ASP2246, or a sham surgery without the drug. After surgery, hospital observation lasts about 2 weeks, and participants receive rehabilitation therapy three times per week for up to 12 weeks. Throughout the study, participants undergo physical therapy and safety monitoring for up to one year after surgery. Researchers will track treatment side effects, brain function assessments, immune responses, and motor recovery using scales like the Fugl-Meyer Assessment and modified Rankin Scale. The study includes detailed follow-ups to evaluate the drugs effects and patient wellbeing over time.

A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke