Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event International, multi-centre, randomized, double-blind placebo-controlled phase II study.
- Conditions
- Cerebrovascular accidentsCVA stroke
- Registration Number
- NL-OMON43310
- Lead Sponsor
- Institut de Recherches Internationales Servier I.R.I.S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- Patients aged between 18 and 80 years (both inclusive),
- Acute ischemic stroke (IS) that occurred at least 48 hours (2 days) and less than 144 hours (6 days) (both inclusive) before selection. If the exact stroke onset time is unknown, by convention it will be defined as the moment the patient was seen well for the last time. Those patients can be included if the time interval between last seen well and stroke discovery is less than 12 hours,
- No previous disability (neither physical nor cognitive pre-stroke impairment),
- NIHSS 7-20 (both inclusive),
- Patient clinically stable according to the investigator's judgement.
- Inclusion done between 72 hours (3 days) and 144 hours (6 days) (both inclusive) after IS onset,
- Brain MRI results available with at least DWI, T2*, FLAIR,
- Brain MRI showing an acute supratentorial cortical ischemic stroke responsible for the clinical picture of the patient.
- Impossibility to undertake an adequate rehabilitation in a specialised centre, and / or ambulatory rehabilitation services
- Stroke due to cerebral venous thrombosis,
- Vascular surgery or endovascular treatment likely to be required during the next 3 months
- Severe co-morbid medical conditions with a life expectancy <12 months or any other disease or condition which would place a patient at undue risk by being included in the study or likely to interfere significantly with the evaluation criteria of the study (according to the investigator's opinion)
- Class III or class IV Heart failure according to the New York Heart Association (NYHA) classification,
- Chronic alcohol abuse1 or drug abuse or addiction, as judged by the investigator (excluding nicotine).
- Pre-existing psychiatric disease likely to impact the clinical evaluation during the study,
- Epileptic seizure during the last 2 years or treatment for epilepsy during the last 12 months,
- Known positive HIV serology, unresolved hepatitis B and/or C infection,
- Pre-stroke known clinically significant cognitive impairment (i.e with impact on daily activities) or known dementia,
- Known severe renal impairment:
- Severe hepatic impairment or known liver enzymes abnormalities
- Contraindication or unable to perform a MRI
- Long-term prescription of benzodiazepine (BZD) that cannot be stopped without exposing the patient to safety risk
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study
- Female patients with child bearing potential and procreative male patients not willing to use effective contraception methods throughout the treatment period and at least 15 days post last treatment intake.
- Brain MRI showing
o a severe microangiopathy,
o an acute haemorrhagic stroke or an important haemorrhagic transformation of the brain infarct ,
o an acute ischemic or haemorrhagic lesion in brain stem or cerebellum likely to contribute significantly to the clinical picture of the patient,
o acute lacunar infarction in the territory of a deep perforating artery likely to contribute significantly to the clinical picture of the patient,
o signs of a pre-existing severe cerebrovascular disease
- Follow-up showing symptomatic haemorrhagic transformation of the cerebral infarction (Symptomatic defined clinically as a worsening of at least 4 points on the NIHSS),
- Repeated demonstration of ECG QTcf > 480ms (at least 2 ECGs out of 3 with a QTcf > 480ms),
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study is to demonstrate the superiority of at lest<br /><br>one of the two doses of S44819 versus placebo on functional recovery from<br /><br>ischaemic stroke measured with the mRS after 90 days of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are:<br /><br>- to assess the efficacy of two doses of S44819 in stroke recovery using<br /><br>neurological evaluations (NIHSS), activities of daily living test (BI) and<br /><br>cognitive performance tests (Moca, TMT)<br /><br>- to assess the safety and tolerability of S44819.</p><br>