A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke
- Registration Number
- NCT02928393
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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 (</=) 35
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo matched to basmisanil orally twice daily for 90 days. Basmisanil Basmisanil Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.
- Primary Outcome Measures
Name Time Method Change From Baseline in FMMS Score at Day 90 Baseline (Day 1), Day 90 Number of Participants with Adverse Events Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118) Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30 Baseline (Day 1), Day 30 Change From Baseline in MoCA Score at Day 90 Baseline (Day 1), Day 90 Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3 Baseline (Day 1), Day 3 Change From Baseline in NIHSS Score At Day 10 Baseline (Day 1), Day 10 Change From Baseline in NIHSS Score At Day 30 Baseline (Day 1), Day 30 Change From Baseline in NIHSS Score At Day 90 Baseline (Day 1), Day 90 Change From Baseline in NIHSS Score At 28 Days After Last Dose Baseline (Day 1) and at 28 days after last dose of study drug (latest on Day 118) Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3 Baseline (Day 1), Day 3 Change From Baseline in C-SSRS Score At Day 30 Baseline (Day 1), Day 30 Change From Baseline in C-SSRS Score At Day 60 Baseline (Day 1), Day 60 Change From Baseline in C-SSRS Score At Day 90 Baseline (Day 1), Day 90 Change From Baseline in C-SSRS Score At 28 Days After Last Dose Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90 Baseline (Day 1), Day 90 mRS Score At Day 90 Day 90 Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90 Baseline (Day 1), Day 90 Change From Baseline in FMA Subscale Score at Day 90 Baseline (Day 1), Day 90 Apparent Oral Clearance (CL/F) of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 Maximum Observed Plasma Concentration (Cmax) of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 Apparent Volume of Distribution at Steady States (Vss) of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 Area Under the Curve [AUC] of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3
Trial Locations
- Locations (13)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
🇫🇷Besançon, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
🇫🇷Clermont-Ferrand, France
Hôpital General - Service de neurologie; Service de neurologie
🇫🇷Dijon Cedex, France
La Paz University Hospital
🇪🇸Madrid, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clnico Universitario de Zaragoza
🇪🇸Zaragoza, Spain
Hôpital Pellegrin Tripode - CHU de Bordeaux
🇫🇷Bordeaux, France
Hopital la Cavale Blanche
🇫🇷brest Cedex 2, France
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hopital Purpan
🇫🇷Toulouse Cedex 9, France
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
🇪🇸Barcelona, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain