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Completed

NCT Number: NCT02877615

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Adelaide Hospital Department of Neurology, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S 44819 150 mg twice a day

Drug

One sachet of S 44819 150 mg and one sachet of placebo twice a day

S 44819 300 mg twice a day

Drug

Two sachets of S 44819 150 mg twice a day

Placebo

Drug

Two sachets of placebo twice a day

Primary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: Up to 90 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2016
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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