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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.
Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Besançon, France
Hôpital Pellegrin Tripode - CHU de Bordeaux
Bordeaux, France
Hopital la Cavale Blanche
Brest, France
Change From Baseline in FMMS Score at Day 90
Time frame: Baseline (Day 1), Day 90
Number of Participants with Adverse Events
Time frame: 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
Time frame: Baseline (Day 1), Day 30
Change From Baseline in MoCA Score at Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3
Time frame: Baseline (Day 1), Day 3
Change From Baseline in NIHSS Score At Day 10
Time frame: Baseline (Day 1), Day 10
Change From Baseline in NIHSS Score At Day 30
Time frame: Baseline (Day 1), Day 30
Change From Baseline in NIHSS Score At Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in NIHSS Score At 28 Days After Last Dose
Time frame: 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
Time frame: Baseline (Day 1), Day 3
Change From Baseline in C-SSRS Score At Day 30
Time frame: Baseline (Day 1), Day 30
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Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, France
Hôpital General - Service de neurologie; Service de neurologie
Dijon, France
Hopital Purpan
Toulouse, France
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
La Paz University Hospital
Madrid, Spain
...and 3 more locations
Change From Baseline in C-SSRS Score At Day 60
Time frame: Baseline (Day 1), Day 60
Change From Baseline in C-SSRS Score At Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in C-SSRS Score At 28 Days After Last Dose
Time frame: Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)
Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90
Time frame: Baseline (Day 1), Day 90
mRS Score At Day 90
Time frame: Day 90
Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in FMA Subscale Score at Day 90
Time frame: Baseline (Day 1), Day 90
Apparent Oral Clearance (CL/F) of Basmisanil
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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