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

December 28, 2018 updated by: Hoffmann-La Roche

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
      • Bordeaux, France, 33076
        • Hopital Pellegrin Tripode - CHU de Bordeaux
      • Clermont-Ferrand, France, 63003
        • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
      • Dijon Cedex, France, 21079
        • Hôpital General - Service de neurologie; Service de neurologie
      • Toulouse Cedex 9, France, 31059
        • Hopital Purpan
      • brest Cedex 2, France, 29609
        • Hopital La Cavale Blanche
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
      • Madrid, Spain
        • La Paz University Hospital
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Zaragoza, Spain, 50009
        • Hospital Clnico Universitario de Zaragoza
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Basmisanil
Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.
Drug: Basmisanil
Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.
Other Names:
  • RO5186582
Placebo Comparator: Placebo
Placebo matched to basmisanil orally twice daily for 90 days.
Drug: Placebo
Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in FMMS Score at Day 90
Time Frame: Baseline (Day 1), Day 90
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)
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
Baseline (Day 1), Day 30
Change From Baseline in MoCA Score at Day 90
Time Frame: Baseline (Day 1), Day 90
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
Baseline (Day 1), Day 3
Change From Baseline in NIHSS Score At Day 10
Time Frame: Baseline (Day 1), Day 10
Baseline (Day 1), Day 10
Change From Baseline in NIHSS Score At Day 30
Time Frame: Baseline (Day 1), Day 30
Baseline (Day 1), Day 30
Change From Baseline in NIHSS Score At Day 90
Time Frame: Baseline (Day 1), Day 90
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)
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
Baseline (Day 1), Day 3
Change From Baseline in C-SSRS Score At Day 30
Time Frame: Baseline (Day 1), Day 30
Baseline (Day 1), Day 30
Change From Baseline in C-SSRS Score At Day 60
Time Frame: Baseline (Day 1), Day 60
Baseline (Day 1), Day 60
Change From Baseline in C-SSRS Score At Day 90
Time Frame: Baseline (Day 1), Day 90
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)
Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90
Time Frame: Baseline (Day 1), Day 90
Baseline (Day 1), Day 90
mRS Score At Day 90
Time Frame: Day 90
Day 90
Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90
Time Frame: Baseline (Day 1), Day 90
Baseline (Day 1), Day 90
Change From Baseline in FMA Subscale Score at Day 90
Time Frame: Baseline (Day 1), Day 90
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP29937
  • 2015-003227-66 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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