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

NCT02928393

TerminatedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Stroke

Interventions: Basmisanil, Placebo

Countries: France, Spain

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (13)
  • Besançon, France
  • Bordeaux, France
  • Brest, France
  • Clermont-Ferrand, France
  • Dijon, France
  • Toulouse, France
  • Majadahonda, Madrid, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Seville, Spain
  • Seville, Spain
  • Zaragoza, Spain