Actively Recruiting
A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke
Led by Astellas Pharma Inc · Updated on 2026-04-15
84
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. After this, they will have physical therapy and continue to have safety checks for about 1 year after their brain surgery.
CONDITIONS
Official Title
A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- First-ever ischemic cerebral infarction at least 3 months but not more than 12 months before consent
- Current neuromotor dysfunction with modified Rankin Scale score between 2 and 4
- Fugl-Meyer Assessment upper extremity score between 20 and 50 and lower extremity score less than 21
- Stroke due to supratentorial perforator area infarction confirmed by MRI
- Completed recovery phase rehabilitation with no expected spontaneous improvement
- Willing and physically able to participate in rehabilitation therapy during the study
- Female participants not pregnant and meeting contraception or breastfeeding restrictions
- Male participants agreeing to contraception or abstinence as specified
- No participation in another interventional study during the 52-week study period
- Use of antiplatelet, anticoagulant, or NSAIDs managed according to guidelines after surgery
You will not qualify if you...
- Cerebral infarct volume greater than 3.4 cm³ or less than 0.37 cm³
- Primary intracerebral or intracranial hemorrhage
- History or current central nervous system malignancy unless in remission over 5 years (except treated basal or squamous cell skin cancer)
- Motor dysfunction with premorbid modified Rankin Scale score above 2
- History of seizures
- Joint contractures impeding movement at major joints
- Spasticity grade 2 or higher on modified Ashworth Scale
- Other neurological, neuromuscular, or orthopedic diseases limiting motor function
- Active infection or immunodeficiency
- High risk of recurrent stroke during study period
- Uncontrolled systemic illnesses including hypertension, bleeding disorders, diabetes, organ failure, morbid obesity, or sleep apnea
- Positive findings for occult malignancy without nonmalignant cause
- Uncontrolled major psychiatric illness including depression with Hamilton Score over 14
- Presence of craniectomy without bone flap or contraindications for stereotactic surgery
- Signs of intracranial herniation or increased intracranial pressure
- Recent myocardial infarction, major heart rhythm problems, atrial fibrillation, or heart failure
- Substance-related or addictive disorders including drug or alcohol use
- Contraindications to MRI or MRI contrast agents
- Montreal Cognitive Assessment score below 26
- History or risk of suicide attempts or suicidal ideation within 12 months
- Use of warfarin or direct oral anticoagulants within 6 months unless embolic source resolved
- Use of neuroleptic drugs within 6 months if psychiatric symptoms unstable
- Use of antiepileptic drugs for seizures unless assessed safe
- Recent interventional treatments for spasticity within 3 months except bracing or splinting
- Previous participation in a study with ASP2246
- Receipt of investigational therapy within 28 days or 5 half-lives before screening
- Inadequate organ function based on lab tests
- Any condition making study participation unsuitable
- Known or suspected allergy to ASP2246 or its components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Toyama University Hospital
Toyama, Toyama, Japan
Actively Recruiting
Research Team
A
Astellas Pharma Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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