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

Roche

Status and phase: Terminated; Phase 2

Conditions: Stroke

Treatments: Drug: Basmisanil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02928393

BP29937

2015-003227-66 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

Basmisanil

Experimental group

Description:

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

Treatment:

Drug: Basmisanil

Placebo

Placebo Comparator group

Description:

Placebo matched to basmisanil orally twice daily for 90 days.

Treatment:

Drug: Placebo