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Trial record 1 of 13 for:    RESTORE AND stroke AND recovery
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Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Servier ( Institut de Recherches Internationales Servier )
Sponsor:
Collaborator:
ADIR Association
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )
ClinicalTrials.gov Identifier:
NCT02877615
First received: July 20, 2016
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by Servier ( Institut de Recherches Internationales Servier ):

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

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 580
Actual Study Start Date: December 19, 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02877615

Contacts
Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinicaltrials@servier.com

  Show 87 Study Locations
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR Association
  More Information

Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02877615     History of Changes
Other Study ID Numbers: CL2-44819-004
2016-001005-16 ( EudraCT Number )
UTN number: U1111-1180-8991 ( Other Identifier: WHO )
Study First Received: July 20, 2016
Last Updated: May 23, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 28, 2017