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

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Servier Protocol Code: CL2-44819-004 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02877615 EudraCT Number: 2016-001005-16

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 121 locations

Study description

This study was done to test a new drug called S44819 (study drug), in patients who had a recent ischemic stroke.

An ischemic stroke is a sudden lack of blood in the brain. It is caused by the blockage of a blood vessel known as an artery. Without blood, the brain tissue is damaged. Symptoms include dizziness, numbness, weakness on one side of the body, and problems with talking, writing, or understanding language. A stroke is also called a cerebrovascular accident.

The main objective of the study was to test if S44819 works better than a placebo on recovery after a stroke. A placebo is a medicine that looks like the study drug but contains no active ingredients.

This study is called a phase 2 study.

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)
Results
English (USA)
English (USA)
Conditions
Post Stroke Recovery
Interventions / Treatments
  • S 44819 150 mg twice a day
  • S 44819 300 mg twice a day
  • Placebo
Other study id numbers
  • CL2-44819-004

Eligibility Criteria

Eligible age for the study

18 years to 85 years (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants had to:

  • Be aged from 18 to
  • Have had an ischemic stroke in the before the start of the study.
  • Not have any previous disability.

Participants were not able to take part in the study if:

  • They had any serious kidney or liver problems.
  • Their brain scans show severe damage in the small blood vessels in the brain.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: S44819 150 mg twice a day
Intervention / Treatment
Drug: S44819

One packet of S44819 (150 mg) and one packet of a placebo twice a day.

Participant Group / Arm
Experimental: S44819 300 mg twice a day
Intervention / Treatment
Drug: S44819

Two packets of S44819 150 mg twice a day.

Participant Group / Arm
Placebo Comparator: Placebo

The placebo looks like the study drug but contains no active ingredients.

Intervention / Treatment
Drug: Placebo

Two packets of placebo twice a day.