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

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ClinicalTrials.gov Identifier: NCT02928393
Recruitment Status : Terminated (Low participant enrolment)
First Posted : October 10, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Basmisanil Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : November 5, 2017
Actual Study Completion Date : November 5, 2017

Arm Intervention/treatment
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 Name: 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.




Primary Outcome Measures :
  1. Change From Baseline in FMMS Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  2. 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) ]
  3. Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30 [ Time Frame: Baseline (Day 1), Day 30 ]
  4. Change From Baseline in MoCA Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  5. Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3 [ Time Frame: Baseline (Day 1), Day 3 ]
  6. Change From Baseline in NIHSS Score At Day 10 [ Time Frame: Baseline (Day 1), Day 10 ]
  7. Change From Baseline in NIHSS Score At Day 30 [ Time Frame: Baseline (Day 1), Day 30 ]
  8. Change From Baseline in NIHSS Score At Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  9. 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) ]
  10. Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3 [ Time Frame: Baseline (Day 1), Day 3 ]
  11. Change From Baseline in C-SSRS Score At Day 30 [ Time Frame: Baseline (Day 1), Day 30 ]
  12. Change From Baseline in C-SSRS Score At Day 60 [ Time Frame: Baseline (Day 1), Day 60 ]
  13. Change From Baseline in C-SSRS Score At Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  14. 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) ]

Secondary Outcome Measures :
  1. Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  2. mRS Score At Day 90 [ Time Frame: Day 90 ]
  3. Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  4. Change From Baseline in FMA Subscale Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928393


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02928393     History of Changes
Other Study ID Numbers: BP29937
2015-003227-66 ( EudraCT Number )
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:
Stroke
Motor impairment
Stroke recovery
Middle cerebral artery stroke
Fugl Meyer
Fugl-Meyer Motor Scale (FMMS)

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases