MEPIVACAINE HYDROCHLORIDE for Ischemic stroke

Inclusion criteria

• {"criterion_text":"- Ischemic stroke more than 30 days old\n- Age between 18 and 85 years old\n- At least one deficit among: motor deficit: score < 56 on the Fugl-Meyer scale aphasia: score ≥4 on the Aphasia Rapid Test, presence of a clinically observable visual scotoma\n- Having given their written consent\n- Be affiliated with a social security scheme, Universal Medical Coverage (CMU) or any equivalent scheme"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to amide-bonded local anesthetics.\n- Atrioventricular conduction disorders requiring permanent electro-systolic training not yet performed.\n- Epilepsy not controlled by treatment.\n- Porphyritic subjects.\n- Patients with a motor deficit (but no aphasia or scotomas) in whom there is spasticity leading to a major reduction in joint amplitude in passive motion\n- Minor patients, under curatorship or guardianship, under legal protection, deprived of liberty, pregnant or breastfeeding women\n- Pathologies involving the vital prognosis or compromising follow-up during the study period\n- Patient undergoing local amine anesthesia in the 7 days preceding V1.\n- Patients currently treated with no anti-arrhythmics such as tocainide, aprindine and mexiletine\n- Patients with a contraindication to MRI (ferro-magnetic surgical clips, eye implants, metallic foreign body intraocular or in the nervous system, implants or metallic objects likely to contain the radiofrequency field, cochlear implants, cerebral or cardiac pacemaker , implantable cardiac defibrillators)\n- Patients participating in research involving the therapeutic human person who may modify functional recovery (whether by medication or by medical device) or subject to an exclusion period for another research"}

Primary endpoints

• {"endpoint_text":"- he response is defined as an improvement 1h (+/- 30min) after injection, compared to the evaluation before mepivacaine injection, on at least one of the clinical scores specific to the symptoms: language, motor skills, visual skills","definition_or_measurement_approach":"Response defined as an improvement 1h (+/- 30min) after injection compared to evaluation before mepivacaine injection on at least one of the clinical scores specific to the symptoms: language, motor skills, visual skills."}

France

Earliest CTIS Part Ii Submission Date

11-07-2024

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

650

Number Of Sites

1

Number Of Participants

38

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"ASPEN PHARMA TRADING LIMITED","duties_or_roles":"Marketing authorisation / product holder for CARBOCAINE 20 mg/ml, solution injectable","organisation_type":""}