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

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 ova after undergoing surgery and for 180 days after surgery.
• •Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) for a minimum of 180 days after surgery.
• •Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for a minimum of 180 days after surgery.
• •Male participant must not donate sperm for a minimum of 180 days after surgery.
• •Participant agrees not to participate in another interventional study (including rehabilitation) while receiving study intervention/participating for up to 52 weeks in the present study.
• •Participant agrees that the use of antiplatelet, oral anticoagulant or nonsteroidal anti-inflammatory drugs (NSAIDs) will be determined by the local medical staff in accordance with the American College of Chest Physicians Clinical Pharmacy 2022 Guidelines and the Japanese Guidelines for the Management of Stroke 2021. The Japanese guidelines specify that no antiplatelet, oral anticoagulant or NSAIDs are to be restarted post-surgery until results of the day 1 head MRI or computerized tomography (CT) are reviewed and restarting medication is deemed safe.
• •Participant has a history of antiepileptic drug use for seizures. Note: For the participant who has used or is using antiepileptic medications for conditions other than seizures, a detailed risk assessment needs to be conducted to determine eligibility.
• •Participant has had botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) within the previous 3 months.
• •Participant has present or previous history of participation in a study with ASP2246.
• •Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• •Participant has inadequate organ function as indicated by the laboratory values at screening.
• •Participant has any condition that makes the participant unsuitable for study participation.
• •Participant has known or suspected hypersensitivity to ASP2246 or any components of the formulation used.