Clinical trial NCT02928393: A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults With Severe Motor Impairment Following an Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke
Motor impairment
Stroke recovery
Middle cerebral artery stroke
Fugl Meyer
Fugl-Meyer Motor Scale (FMMS)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-10-10
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 (\</=) 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

Primary outcomes:
measure: Change From Baseline in FMMS Score at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Number of Participants with Adverse Events
timeFrame: Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118)
measure: Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30
timeFrame: Baseline (Day 1), Day 30
measure: Change From Baseline in MoCA Score at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3
timeFrame: Baseline (Day 1), Day 3
measure: Change From Baseline in NIHSS Score At Day 10
timeFrame: Baseline (Day 1), Day 10
measure: Change From Baseline in NIHSS Score At Day 30
timeFrame: Baseline (Day 1), Day 30
measure: Change From Baseline in NIHSS Score At Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in NIHSS Score At 28 Days After Last Dose
timeFrame: Baseline (Day 1) and at 28 days after last dose of study drug (latest on Day 118)
measure: Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3
timeFrame: Baseline (Day 1), Day 3
measure: Change From Baseline in C-SSRS Score At Day 30
timeFrame: Baseline (Day 1), Day 30
measure: Change From Baseline in C-SSRS Score At Day 60
timeFrame: Baseline (Day 1), Day 60
measure: Change From Baseline in C-SSRS Score At Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in C-SSRS Score At 28 Days After Last Dose
timeFrame: Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)
Secondary outcomes:
measure: Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90
timeFrame: Baseline (Day 1), Day 90
measure: mRS Score At Day 90
timeFrame: Day 90
measure: Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in FMA Subscale Score at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Apparent Oral Clearance (CL/F) of Basmisanil
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of Basmisanil
timeFrame: 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
measure: Apparent Volume of Distribution at Steady States (Vss) of Basmisanil
timeFrame: 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
measure: Area Under the Curve [AUC] of Basmisanil
timeFrame: 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
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
city: Bordeaux
country: France
facility: Hôpital Pellegrin Tripode - CHU de Bordeaux
city: brest Cedex 2
country: France
facility: Hopital la Cavale Blanche
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
city: Dijon Cedex
country: France
facility: Hôpital General - Service de neurologie; Service de neurologie
city: Toulouse Cedex 9
country: France
facility: Hopital Purpan
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: La Paz University Hospital
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Zaragoza
country: Spain
facility: Hospital Clnico Universitario de Zaragoza
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: