A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke (NCT07318714) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke
Japan84 participantsStarted 2026-04-03
Plain-language summary
This study is for adults who have difficulty moving a few months after a stroke. In this study, ASP2246 will be given to people for the first time. This is known as a "first in human" study.
The main aims of the study are to check the safety of ASP2246, how well people tolerate it, and to find suitable doses of ASP2246 to use later in this study and in future studies.
This study has 2 parts. In Part 1, people will have brain surgery. During the surgery, different small groups of people will receive a lower to a higher dose of ASP2246. Each dose will be given slowly through a special tube to the damaged part of the brain (intracerebral parenchymal infusion). Any medical problems will be recorded at each dose. This is done to find suitable doses to use in Part 2 of the study.
In Part 2, other different groups of people will undergo the same type of brain surgery. Some people will receive a higher dose of ASP2246, and some people will receive a lower dose of ASP2246. These are the doses from Part 1. Also, another group of people won't be given ASP2246 during brain surgery. This is known as a sham procedure. This is done so neither the people taking part in Part 2, nor the study doctors (apart from the surgeons) know who will be given ASP2246.
After brain surgery, people will be observed for about 2 weeks. For people in Part 1, this will take place in the hospital. For people in Part 2, the observation in hospital may be longer or shorter, depending on the results from Part 1. People in both Parts 1 and 2 will have physical therapy for 12 weeks after surgery and continue to have safety checks for about 1 year after their brain surgery.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant should have had an ischemic cerebral infarction at least 3 months, but not more than 12 months, before signing informed consent. This stroke must be the first-ever stroke for the participant.
* Participant has current neuromotor dysfunction with a modified Rankin Scale (mRS) score between 2 to 4 at screening.
* Participant has Fugl-Meyer Assessment (FMA)- upper extremity (UE) score ≥ 20 to ≤ 50 and FMA-lower extremity (LE) score \< 21 at screening.
* Participant has supratentorial perforator area infarction (single lacunar infarction or branch-atheromatous disease \[BAD\]), as assessed clinically and by magnetic resonance imaging (MRI) at screening.
* Participant has completed recovery phase rehabilitation after cerebral infarction and spontaneous improvement is not expected during the study period.
* Participant is willing and physically able to participate in the designated rehabilitation therapy during the study period.
* Female participant is not pregnant and at least 1 of the following conditions apply:
* Not a woma(e)n of childbearing potential (WOCBP)
* WOCBP who has a negative urine or serum pregnancy test at screening (Unique to Japan: with a medical interview) and agrees to follow contraceptive guidance from the time of giving informed consent to at least 180 days after surgery.
* Female participant must not be breastfeeding or lactating starting at screening and for 180 days after surgery.
* Female participant must not donate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Dose-Limiting Toxicity (DLT)
Timeframe: Up to 2 Weeks
2
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to 52 Weeks
3
Number of participants with Serious Adverse Events (SAEs)
Timeframe: Up to 52 Weeks
4
Number of participants with an Adverse Event of Special Interest (AESI)
Timeframe: Up to 52 Weeks
5
Number of Participants with Suicidal Ideation and/or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)