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

• Status: Terminated
• Trial end date: 2017-11-03
• Target enrollment: 0
• Participant gender: All

Summary

This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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