Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
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ClinicalTrials.gov Identifier: NCT02877615 |
Recruitment Status :
Completed
First Posted : August 24, 2016
Last Update Posted : March 11, 2020
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Condition or disease | Intervention/treatment | Phase |
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Post Stroke Recovery | Drug: S 44819 150 mg twice a day Drug: S 44819 300 mg twice a day Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 585 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Efficacy and Safety Trial With Oral S 44819 After Recent Ischemic Cerebral Event. International, Multi-centre, Randomized, Doubleblind Placebo-controlled Phase II Study. (RESTORE BRAIN Study) |
Actual Study Start Date : | December 19, 2016 |
Actual Primary Completion Date : | March 10, 2019 |
Actual Study Completion Date : | March 10, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: S 44819 150 mg twice a day |
Drug: S 44819 150 mg twice a day
One sachet of S 44819 150 mg and one sachet of placebo twice a day |
Experimental: S 44819 300 mg twice a day |
Drug: S 44819 300 mg twice a day
Two sachets of S 44819 150 mg twice a day |
Placebo Comparator: Placebo |
Drug: Placebo
Two sachets of placebo twice a day |
- Modified Rankin Scale (mRS) [ Time Frame: Up to 90 days ]
- National Institutes of Health Stroke Scale (NIHSS) total score [ Time Frame: Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 ]Efficacy criterion
- Barthel Index (BI) total score [ Time Frame: Day 30 Day 60 Day 90 Day 105 ]Efficacy criterion
- Montreal Cognitive Assessment scale (Moca) total score [ Time Frame: Day 30 Day 90 ]Efficacy criterion
- Trail Making Test (TMT) time for part A [ Time Frame: Day 30 Day 90 ]Efficacy criterion
- Adverse events [ Time Frame: Through study completion, an average of 3 months ]Safety criterion
- Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 5 Day 30 Day 60 Day 90 Day 105 ]Safety criterion
- Body weight [ Time Frame: Selection visit Day 30 Day 60 Day 90 Day 105 ]Safety criterion
- Vital signs (supine for Systolic and Diastolic Blood Pressure) [ Time Frame: Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 ]Safety criterion
- 12 lead-ECG [ Time Frame: Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 ]Safety criterion
- Trail Making Test (TMT) time for part B [ Time Frame: Day 30 Day 90 ]Efficacy criterion

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- Patients aged between 18 and 85 years (both inclusive)
- Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion
Exclusion criteria :
- Any non-selection criteria, which could have occurred after the selection visit
- Positive urinary or blood pregnancy test (for female patients of child bearing potential)
- Any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome
- Severe renal impairment detected in the local laboratory test
- Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test
- Stroke due to cerebral venous thrombosis
- Brain MRI showing a severe microangiopathy
- Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct
- Qualifying ischemic cerebral event older than 192 hours at inclusion
- Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome,
- Repeated prolongation of ECG QTcF
- Patient or authorised representative refusing to attend study visits or to take part in the study

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): NCT02877615

Study Data/Documents: Study Protocol

Publications of Results:
Other Publications:
Responsible Party: | Institut de Recherches Internationales Servier |
ClinicalTrials.gov Identifier: | NCT02877615 |
Other Study ID Numbers: |
CL2-44819-004 2016-001005-16 ( EudraCT Number ) UTN number: U1111-1180-8991 ( Other Identifier: WHO ) |
First Posted: | August 24, 2016 Key Record Dates |
Last Update Posted: | March 11, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. They can ask all interventional clinical studies:
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Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After Marketing Authorisation in EEA or US if the study is used for the approval. |
Access Criteria: | Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed. |
URL: | https://clinicaltrials.servier.com |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
S44819 GABA-A Receptor Antagonists GABA Antagonists GABA Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |