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

Recruiting

Phase 2 Results N/A

Update History

13 Oct '17
The Summary of Purpose was updated.
New
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.
Old
This Phase 2a, 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.
The minimum age criteria for eligibility was updated to "40 Years."
The eligibility criteria were updated.
New
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 () 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
Old
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 () 20 - Severe aphasia that prevents a participant from adequately completing study assessments - Significant deficit from prior strokes or pre-existing motor deficit - History of epilepsy, neurosurgery, severe head trauma or central nervous system (CNS) 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
A location was updated in Besançon.
New
The overall status was updated to "Recruiting" at CHU de Besancon Hopital Jean Minjoz; Service de Neurologie.
A location was updated in Clermont-Ferrand.
New
The overall status was updated to "Recruiting" at Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B.
A location was updated in Dijon Cedex.
New
The overall status was updated to "Recruiting" at Hôpital General; Hôpital du Bocage - Service de neurologie.
29 Jul '17
The eligibility criteria were updated.
New
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 () 20 - Severe aphasia that prevents a participant from adequately completing study assessments - Significant deficit from prior strokes or pre-existing motor deficit - History of epilepsy, neurosurgery, severe head trauma or central nervous system (CNS) 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
Old
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 () 20 - Severe aphasia that prevents a participant from adequately completing study assessments - Significant deficit from prior strokes or pre-existing motor deficit - History of epilepsy, neurosurgery, severe head trauma or central nervous system (CNS) 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
3 Jul '17
The gender criteria for eligibility was updated to "All."