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

Terminated

Phase 2 Results N/A

Update History

10 Jan '18
A location was updated in Besançon.
New
The overall status was removed for CHU de Besancon Hopital Jean Minjoz; Service de Neurologie.
A location was updated in Bordeaux.
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The overall status was removed for Hôpital Pellegrin Tripode - CHU de Bordeaux.
A location was updated in brest Cedex 2.
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The overall status was removed for Hopital la Cavale Blanche.
A location was updated in Clermont-Ferrand.
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The overall status was removed for Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B.
A location was updated in Dijon Cedex.
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The overall status was removed for Hôpital General; Hôpital du Bocage - Service de neurologie.
A location was updated in Toulouse Cedex 9.
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The overall status was removed for Hopital Purpan.
A location was updated in Majadahonda.
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The overall status was removed for Hospital Universitario Puerta de Hierro.
A location was updated in Barcelona.
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The overall status was removed for Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia.
A location was updated in Barcelona.
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The overall status was removed for Hospital Universitari Vall d'Hebron.
A location was updated in Madrid.
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The overall status was removed for La Paz University Hospital.
A location was updated in Sevilla.
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The overall status was removed for Hospital Universitario Virgen Macarena.
A location was updated in Sevilla.
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The overall status was removed for Hospital Virgen del Rocío.
A location was updated in Zaragoza.
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The overall status was removed for Hospital Clnico Universitario de Zaragoza.
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 removed for CHU de Besancon Hopital Jean Minjoz; Service de Neurologie.
A location was updated in Clermont-Ferrand.
New
The overall status was removed for Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B.
A location was updated in Dijon Cedex.
New
The overall status was removed for 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."