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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02928393
• Other study ID #: BP29937
• Secondary ID: 2015-003227-66
• Status: Terminated
• Phase: Phase 2
• Start date: February 20, 2017
• Est. completion date: November 3, 2017

Study information

• Verified date: December 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Basmisanil
Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.
• Placebo
Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.

Locations

Country	Name	City	State
France	CHU de Besancon Hopital Jean Minjoz; Service de Neurologie	Besançon
France	Hôpital Pellegrin Tripode - CHU de Bordeaux	Bordeaux
France	Hopital la Cavale Blanche	brest Cedex 2
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	Hopital Purpan	Toulouse Cedex 9
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	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospital Clnico Universitario de Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in FMMS Score at Day 90		Baseline (Day 1), Day 90
Primary	Number of Participants with Adverse Events		Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118)
Primary	Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30		Baseline (Day 1), Day 30
Primary	Change From Baseline in MoCA Score at Day 90		Baseline (Day 1), Day 90
Primary	Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3		Baseline (Day 1), Day 3
Primary	Change From Baseline in NIHSS Score At Day 10		Baseline (Day 1), Day 10
Primary	Change From Baseline in NIHSS Score At Day 30		Baseline (Day 1), Day 30
Primary	Change From Baseline in NIHSS Score At Day 90		Baseline (Day 1), Day 90
Primary	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)
Primary	Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3		Baseline (Day 1), Day 3
Primary	Change From Baseline in C-SSRS Score At Day 30		Baseline (Day 1), Day 30
Primary	Change From Baseline in C-SSRS Score At Day 60		Baseline (Day 1), Day 60
Primary	Change From Baseline in C-SSRS Score At Day 90		Baseline (Day 1), Day 90
Primary	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	Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90		Baseline (Day 1), Day 90
Secondary	mRS Score At Day 90		Day 90
Secondary	Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90		Baseline (Day 1), Day 90
Secondary	Change From Baseline in FMA Subscale Score at Day 90		Baseline (Day 1), Day 90
Secondary	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
Secondary	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
Secondary	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
Secondary	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