NCT02928393

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 stroke

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_2 stroke

Geographic Reach
2 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2017

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

October 7, 2016

Last Update Submit

December 28, 2018

Conditions

Stroke

Keywords

StrokeMotor impairmentStroke recoveryMiddle cerebral artery strokeFugl MeyerFugl-Meyer Motor Scale (FMMS)

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Basmisanil

EXPERIMENTAL

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

Drug: Basmisanil

Placebo

PLACEBO COMPARATOR

Placebo matched to basmisanil orally twice daily for 90 days.

Drug: Placebo

Interventions

BasmisanilDRUG

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

Also known as: RO5186582
Basmisanil
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

Besançon, 25030, France

Location

Hôpital Pellegrin Tripode - CHU de Bordeaux

Bordeaux, 33076, France

Location

Hopital la Cavale Blanche

Brest, 29609, France

Location

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

Clermont-Ferrand, 63003, France

Location

Hôpital General - Service de neurologie; Service de neurologie

Dijon, 21079, France

Location

Hopital Purpan

Toulouse, 31059, France

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

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

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

La Paz University Hospital

Madrid, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clnico Universitario de Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

StrokeInfarction, Middle Cerebral Artery

Interventions

basmisanil

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral InfarctionBrain InfarctionBrain IschemiaCerebral Arterial DiseasesIntracranial Arterial DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 10, 2016

Study Start

February 20, 2017

Primary Completion

November 3, 2017

Study Completion

November 3, 2017

Last Updated

January 2, 2019

Record last verified: 2018-12

Locations

FR(6)ES(7)