A Study to Evaluate the Effectiveness and Safety of Basmisanil (RO5186582) in Adults with Severe Motor Impairment Following an Ischemic Stroke

Phase 1

• Conditions: Stroke Motor Recovery; MedDRA version: 19.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003227-66-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

- Aged 50-80 years
- Radiologic assessment confirming an acute middle cerebral artery ischaemic stroke
- Index stroke occurred within the past 3-4 days
- Availability of brain images and interpretation, medications, blood pressure and blood glucose values from admission until screening for study file
- Inpatient males and females; females must be either surgically sterile (by means of hysterectomy, and/or bilateral oophorectomy) or post-menopausal for at least one year (i.e., continuous amenorrhea) and not receiving oestrogen therapies
- Severe hemiparesis or hemiplegia defined by FMMS score <= 35
- Body mass index 18-34 kilogram per square meter
- Sufficient speech, vision and hearing to participate in study evaluations, as judged clinically by the Investigator
- The presence of a reliable caregiver, able and willing to provide information regarding patient’s behaviour and symptoms and able to administer treatment if patient cannot self-administer when discharged from an outpatient facility during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

Neurological and Psychiatric Assessments and Conditions:
- National Institute of Health Stroke Scale (NIHSS) > 20
- Severe aphasia that prevents a patient from adequately completing study assessments and following directions in rehabilitation
- Significant deficit from prior strokes or pre-existing motor deficit (mRS >= 2 prior to index stroke)
- Received upper and/or lower extremity botulinum toxin within 6 months
- History of epilepsy, neurosurgery, severe head trauma or central nervous system infections (e.g., meningitis) 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 (e.g., requiring hospitalization, alcohol and/or substance use disorder) within 12 months prior to stroke
- History of suicidal behaviour or otherwise considered a high suicidal risk by the Investigator

Cardiovascular Assessments and Conditions:
- Due to undergo carotid surgery within the next 4 months
- Medical history of clinical symptoms of heart failure or coronary artery disease exceeding New York Heart Association Class II
- Severe or treatment-refractory hypotension, hypertension or hyperglycaemia from the immediate post stroke period through screening
- Repeat heart rate below 50 beats per minute (bpm) or above 100 bpm
- Repeat systolic blood pressure above 180 millimetre of mercury (mmHg) or diastolic above 110 mmHg (corresponding to Grade 3 = severe hypertension)
- Repeat systolic blood pressure below 80 mmHg or diastolic below 40 mmHg
- Electrocardiogram (ECG) abnormalities at screening. Atrial fibrillation is allowed

Investigational and Concomitant Medication:
- 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)
- Known hypersensitivity to the excipients of the study drug
- Concomitant use of prohibited medications

Other Medical Assessments and Conditions:
- Clinically relevant medical conditions, e.g., immunological, pulmonary, hepatic, or renal dysfunction, that according to the judgment of the Investigator would likely interfere with the study conduct and scheduled assessments
- History of malignancy if not considered cured or stabilized according to the judgment of the Investigator (i.e., unlikely to affect patient’s performance throughout the next 4 months)
- Donation or loss of blood over 500 millilitre within 3 months prior to randomization
- Evidence of acute infections not considered controlled by anti-infectives
- Clinically significant abnormality in clinical chemistry parameters at the time of screening, including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN); total bilirubin > ULN with the exception of Gilbert syndrome; glycosylated haemoglobin A1c > 9%; serum creatinine exceeding 1.5-fold ULN
- Serology positive for human immunodeficiency virus infection, Hepatitis B or Hepatitis C

Magnetic resonance imaging (MRI)-related Exclusion Criteria:
- Contraindication to MRI (e.g., artificial heart valves, pacemakers, ear implants, foreign metal objects in the eyes, skin or body, etc.) or conditions which render interpret

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified