A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Radiologic assessment confirming an acute middle cerebral artery ischemic stroke
- Index stroke occurred within the past 3-4 days
- Inpatient males and females
- Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to ( - Sufficient speech, vision and hearing to participate in study evaluations

Exclusion Criteria

- NIHSS greater than (>) 20
- Severe aphasia that prevents a participant from following directions in rehabilitation
- Significant deficit from prior strokes or pre-existing motor deficit
- History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months
- Known or suspected clinical seizure post-index stroke
- History of pre-existing dementia or use of medications for dementia
- History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke
- Due to undergo carotid surgery within the next 4 months
- Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer)
- Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments
- Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult