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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003227-66 | EudraCT Number |
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Low participant enrolment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basmisanil | Experimental | Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days. |
|
| Placebo | Placebo Comparator | Placebo matched to basmisanil orally twice daily for 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basmisanil | Drug | Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FMMS Score at Day 90 | Baseline (Day 1), Day 90 | |
| Number of Participants with Adverse Events | Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118) | |
| Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30 | Baseline (Day 1), Day 30 | |
| Change From Baseline in MoCA Score at Day 90 | Baseline (Day 1), Day 90 | |
| Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3 | Baseline (Day 1), Day 3 | |
| Change From Baseline in NIHSS Score At Day 10 | Baseline (Day 1), Day 10 | |
| Change From Baseline in NIHSS Score At Day 30 | Baseline (Day 1), Day 30 | |
| Change From Baseline in NIHSS Score At Day 90 | Baseline (Day 1), Day 90 | |
| Change From Baseline in NIHSS Score At 28 Days After Last Dose | Baseline (Day 1) and at 28 days after last dose of study drug (latest on Day 118) | |
| Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90 | Baseline (Day 1), Day 90 | |
| mRS Score At Day 90 | Day 90 | |
| Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besancon Hopital Jean Minjoz; Service de Neurologie | Besançon | 25030 | France | |||
| Hôpital Pellegrin Tripode - CHU de Bordeaux |
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| Placebo | Drug | Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days. |
|
| Baseline (Day 1), Day 3 |
| Change From Baseline in C-SSRS Score At Day 30 | Baseline (Day 1), Day 30 |
| Change From Baseline in C-SSRS Score At Day 60 | Baseline (Day 1), Day 60 |
| Change From Baseline in C-SSRS Score At Day 90 | Baseline (Day 1), Day 90 |
| Change From Baseline in C-SSRS Score At 28 Days After Last Dose | Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118) |
| Baseline (Day 1), Day 90 |
| Change From Baseline in FMA Subscale Score at Day 90 | Baseline (Day 1), Day 90 |
| Apparent Oral Clearance (CL/F) of Basmisanil | 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 |
| Maximum Observed Plasma Concentration (Cmax) of Basmisanil | 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 |
| Apparent Volume of Distribution at Steady States (Vss) of Basmisanil | 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 |
| Area Under the Curve [AUC] of Basmisanil | 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 |
| Bordeaux |
| 33076 |
| France |
| Hopital la Cavale Blanche | Brest | 29609 | France |
| Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B | Clermont-Ferrand | 63003 | France |
| Hôpital General - Service de neurologie; Service de neurologie | Dijon | 21079 | France |
| Hopital Purpan | Toulouse | 31059 | France |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| La Paz University Hospital | Madrid | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clnico Universitario de Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020244 | Infarction, Middle Cerebral Artery |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C000720034 | basmisanil |
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