Overview
Sponsor-declared trial summary
Ischemic stroke
To assess, in patients with neurological symptoms following ischemic stroke, the rate of responders to an injection of mepivatin subcutaneously
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 23 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514481-39-00
- EudraCT number
- 2021-005507-13
- ClinicalTrials.gov
- NCT05222828
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To assess, in patients with neurological symptoms following ischemic stroke, the rate of responders to an injection of mepivatin subcutaneously
Conditions and MedDRA coding
Ischemic stroke
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Ischemic stroke more than 30 days old Age between 18 and 85 years old 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 Having given their written consent Be affiliated with a social security scheme, Universal Medical Coverage (CMU) or any equivalent scheme
Exclusion criteria 1
- Hypersensitivity to amide-bonded local anesthetics. Atrioventricular conduction disorders requiring permanent electro-systolic training not yet performed. Epilepsy not controlled by treatment. Porphyritic subjects. 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 Minor patients, under curatorship or guardianship, under legal protection, deprived of liberty, pregnant or breastfeeding women Pathologies involving the vital prognosis or compromising follow-up during the study period Patient undergoing local amine anesthesia in the 7 days preceding V1. Patients currently treated with no anti-arrhythmics such as tocainide, aprindine and mexiletine 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) 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CARBOCAINE 20 mg/ml, solution injectable
PRD4875488 · Product
- Active substance
- Mepivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB — AMIDES
- Marketing authorisation
- 34009 341 694 2 7
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Laurent COHEN
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Laurent COHEN
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 38 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-08-23 | 2024-08-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2021-005507-13_PROTOCOLE_MEPI-AVC | 5.0 |
| Recruitment arrangements (for publication) | MEPI-AVC_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | 2021-005507-13_FC genetique_MEPI-AVC | 2.0 |
| Subject information and informed consent form (for publication) | 2021-005507-13_NIFC_MEPI-AVC | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_carbocaine | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | France | Acceptable 2024-08-22
|
2024-08-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-22 | France | Acceptable 2024-08-22
|
2026-04-22 |