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

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo matched to basmisanil orally twice daily for 90 days.
  • Basmisanil Drug
    Other Names: RO5186582
    Intervention Desc: Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.
    ARM 1: Kind: Experimental
    Label: Basmisanil
    Description: Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Day 90 Baseline (Day 1), Day 90 No
Primary Number of Participants with Adverse events (AE) and Serious Adverse Events (SAEs) Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118) No
Primary Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30 Baseline (Day 1), Day 30 No
Primary Change From Baseline in MoCA Score at Day 90 Baseline (Day 1), Day 90 No
Primary Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3 Baseline (Day 1), Day 3 No
Primary Change From Baseline in NIHSS Score At Day 10 Baseline (Day 1), Day 10 No
Primary Change From Baseline in NIHSS Score At Day 30 Baseline (Day 1), Day 30 No
Primary Change From Baseline in NIHSS Score At Day 90 Baseline (Day 1), Day 90 No
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) No
Primary Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3 Baseline (Day 1), Day 3 No
Primary Change From Baseline in C-SSRS Score At Day 30 Baseline (Day 1), Day 30 No
Primary Change From Baseline in C-SSRS Score At Day 60 Baseline (Day 1), Day 60 No
Primary Change From Baseline in C-SSRS Score At Day 90 Baseline (Day 1), Day 90 No
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) No
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, 8, 12 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 No
Secondary Area Under the Curve From Time Zero to 12 Hours [AUC (0 - 12)] of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4, 8, 12 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 No
Secondary Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90 Baseline (Day 1), Day 90 No
Secondary mRS Score At Day 90 Day 90 No
Secondary Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90 Baseline (Day 1), Day 90 No
Secondary Change From Baseline in FMA Subscale Score at Day 90 Baseline (Day 1), Day 90 No
Secondary Apparent Oral Clearance (CL/F) of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4, 8, 12 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 No
Secondary Maximum Observed Plasma Concentration (Cmax) of Basmisanil Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4, 8, 12 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3 No
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)
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

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