Back to results

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

Primary Purpose

Stroke

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Basmisanil

Placebo

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Motor impairment, Stroke recovery, Middle cerebral artery stroke, Fugl Meyer, Fugl-Meyer Motor Scale (FMMS)

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Hôpital Pellegrin Tripode - CHU de Bordeaux
Hopital la Cavale Blanche
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Hôpital General - Service de neurologie; Service de neurologie
Hopital Purpan
Hospital Universitario Puerta de Hierro
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Hospital Universitari Vall d'Hebron
La Paz University Hospital
Hospital Universitario Virgen Macarena
Hospital Virgen del Rocio
Hospital Clnico Universitario de Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Basmisanil

Placebo

Arm Description

Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.

Placebo matched to basmisanil orally twice daily for 90 days.

Outcomes

Primary Outcome Measures

Change From Baseline in FMMS Score at Day 90

Number of Participants with Adverse Events

Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30

Change From Baseline in MoCA Score at Day 90

Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3

Change From Baseline in NIHSS Score At Day 10

Change From Baseline in NIHSS Score At Day 30

Change From Baseline in NIHSS Score At Day 90

Change From Baseline in NIHSS Score At 28 Days After Last Dose

Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3

Change From Baseline in C-SSRS Score At Day 30

Change From Baseline in C-SSRS Score At Day 60

Change From Baseline in C-SSRS Score At Day 90

Change From Baseline in C-SSRS Score At 28 Days After Last Dose

Secondary Outcome Measures

Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90

mRS Score At Day 90

Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90

Change From Baseline in FMA Subscale Score at Day 90

Apparent Oral Clearance (CL/F) of Basmisanil

Maximum Observed Plasma Concentration (Cmax) of Basmisanil

Apparent Volume of Distribution at Steady States (Vss) of Basmisanil

Area Under the Curve [AUC] of Basmisanil

Full Information

NCT ID

NCT02928393

First Posted

October 7, 2016

Last Updated

December 28, 2018

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02928393

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Why Stopped

Low participant enrolment

Study Start Date

February 20, 2017 (Actual)

Primary Completion Date

November 3, 2017 (Actual)

Study Completion Date

November 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Motor impairment, Stroke recovery, Middle cerebral artery stroke, Fugl Meyer, Fugl-Meyer Motor Scale (FMMS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Basmisanil

Arm Type

Experimental

Arm Description

Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo matched to basmisanil orally twice daily for 90 days.

Intervention Type

Drug

Intervention Name(s)

Basmisanil

Other Intervention Name(s)

RO5186582

Intervention Description

Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.

Primary Outcome Measure Information:

Title

Change From Baseline in FMMS Score at Day 90

Time Frame

Baseline (Day 1), Day 90

Title

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)

Title

Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30

Time Frame

Baseline (Day 1), Day 30

Title

Change From Baseline in MoCA Score at Day 90

Time Frame

Baseline (Day 1), Day 90

Title

Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3

Time Frame

Baseline (Day 1), Day 3

Title

Change From Baseline in NIHSS Score At Day 10

Time Frame

Baseline (Day 1), Day 10

Title

Change From Baseline in NIHSS Score At Day 30

Time Frame

Baseline (Day 1), Day 30

Title

Change From Baseline in NIHSS Score At Day 90

Time Frame

Baseline (Day 1), Day 90

Title

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)

Title

Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3

Time Frame

Baseline (Day 1), Day 3

Title

Change From Baseline in C-SSRS Score At Day 30

Time Frame

Baseline (Day 1), Day 30

Title

Change From Baseline in C-SSRS Score At Day 60

Time Frame

Baseline (Day 1), Day 60

Title

Change From Baseline in C-SSRS Score At Day 90

Time Frame

Baseline (Day 1), Day 90

Title

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)

Secondary Outcome Measure Information:

Title

Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90

Time Frame

Baseline (Day 1), Day 90

Title

mRS Score At Day 90

Time Frame

Day 90

Title

Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90

Time Frame

Baseline (Day 1), Day 90

Title

Change From Baseline in FMA Subscale Score at Day 90

Time Frame

Baseline (Day 1), Day 90

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Name

Hôpital Pellegrin Tripode - CHU de Bordeaux

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Hopital la Cavale Blanche

City

brest Cedex 2

ZIP/Postal Code

29609

Country

France

Facility Name

Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Hôpital General - Service de neurologie; Service de neurologie

City

Dijon Cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Hopital Purpan

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Hospital Universitario Puerta de Hierro

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

La Paz University Hospital

City

Madrid

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital Clnico Universitario de Zaragoza

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs