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Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877615
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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Brief Summary:
The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

Condition or disease Intervention/treatment Phase
Post Stroke Recovery Drug: S 44819 150 mg twice a day Drug: S 44819 300 mg twice a day Drug: Placebo Phase 2

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: Up to 90 days ]

Secondary Outcome Measures :
  1. 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

  2. Barthel Index (BI) total score [ Time Frame: Day 30 Day 60 Day 90 Day 105 ]
    Efficacy criterion

  3. Montreal Cognitive Assessment scale (Moca) total score [ Time Frame: Day 30 Day 90 ]
    Efficacy criterion

  4. Trail Making Test (TMT) time for part A [ Time Frame: Day 30 Day 90 ]
    Efficacy criterion

  5. Adverse events [ Time Frame: Through study completion, an average of 3 months ]
    Safety criterion

  6. 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

  7. Body weight [ Time Frame: Selection visit Day 30 Day 60 Day 90 Day 105 ]
    Safety criterion

  8. 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

  9. 12 lead-ECG [ Time Frame: Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 ]
    Safety criterion

  10. Trail Making Test (TMT) time for part B [ Time Frame: Day 30 Day 90 ]
    Efficacy criterion


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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): NCT02877615


Locations
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Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
More Information
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Additional Information:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
Clinical Study Report  This link exits the ClinicalTrials.gov site
Study-level clinical trial data  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

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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:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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S44819
GABA-A Receptor Antagonists
GABA Antagonists
GABA Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs