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

  • Stroke
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Countries
  • France
  • Spain
Trial Identifier:

NCT02928393 2015-003227-66 BP29937

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02928393, BP29937, 2015-003227-66 Trial Identifier
      Basmisanil, Placebo Treatments
      Stroke Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥40 Years & ≤ 85 Years Age
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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