Clinical trial • Phase III • Neurology|Other

LIDOCAINE HYDROCHLORIDE for Spontaneous subarachnoid hemorrhage|Headache secondary to subarachnoid hemorrhage

Phase III trial of LIDOCAINE HYDROCHLORIDE for Spontaneous subarachnoid hemorrhage|Headache secondary to subarachnoid hemorrhage.

Overview

Trial Therapeutic Area
Neurology|Other
Trial Disease
Spontaneous subarachnoid hemorrhage|Headache secondary to subarachnoid hemorrhage
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-02-2025
First CTIS Authorization Date
23-05-2025

Trial design

Intervention (Test): Lidocaína B. Braun 20 mg/ml solución inyectable (active substance: lidocaine hydrochloride), route: subcutaneous injection, max total dose reported: 3 ml. Comparator (Placebo): Suero Fisiológico Braun 0,9% (sodium chloride) solution for injection, route: subcutaneous, max total dose reported: 3 ml.-controlled Phase III trial in Spain.

Comparator
Intervention (Test): Lidocaína B. Braun 20 mg/ml solución inyectable (active substance: lidocaine hydrochloride), route: subcutaneous injection, max total dose reported: 3 ml. Comparator (Placebo): Suero Fisiológico Braun 0,9% (sodium chloride) solution for injection, route: subcutaneous, max total dose reported: 3 ml.
Target Sample Size
40

Eligibility

Recruits 40 isVulnerablePopulationSelected: false; Consent requirement: "Signed informed consent from the patient or their representative." Subject information and informed consent forms available in Spanish and Catalan. No specific paediatric assent or other vulnerable-population procedures described..

Pregnancy Exclusion
Pregnancy or breastfeeding.
Vulnerable Population
isVulnerablePopulationSelected: false; Consent requirement: "Signed informed consent from the patient or their representative." Subject information and informed consent forms available in Spanish and Catalan. No specific paediatric assent or other vulnerable-population procedures described.

Inclusion criteria

  • {"criterion_text":"- Patients with diffuse or perimesencephalic aSAH admitted to the Semicritical Care Unit or ICU of Hospital de la Santa Creu i Sant Pau."}
  • {"criterion_text":"- Hunt and Hess scale 1-3 (see Annex 3)."}
  • {"criterion_text":"- Signed informed consent from the patient or their representative."}

Exclusion criteria

  • {"criterion_text":"- Presence of other causes of secondary headache (AVM, space-occupying lesions, etc.)."}
  • {"criterion_text":"- Pregnancy or breastfeeding."}
  • {"criterion_text":"- Cardiac conduction disorders: Second- or third-degree atrioventricular block. Arrhythmias with hemodynamic instability."}
  • {"criterion_text":"- Convexity SAH."}
  • {"criterion_text":"- Hunt and Hess scale 4 or 5 (see Annex 3)."}
  • {"criterion_text":"- History of allergic reaction to local anesthetic"}
  • {"criterion_text":"- Severe functional dependence (mRS 4-5, see Annex 7)."}
  • {"criterion_text":"- GCS ≤8 prior to the procedure (see Annex 4)."}
  • {"criterion_text":"- Intracranial surgery ≤1 month prior or planned during hospitalization (excluding ventricular drains)."}
  • {"criterion_text":"- Known terminal illness or imminent limitation of therapeutic effort."}
  • {"criterion_text":"- Difficulty or foreseeable loss of clinical follow-up."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Composite variable consisting of headache reduction measured with the Numerical Pain Rating Scale (NPRS) at 1 hour post-procedure, defined as a ≥30% reduction (partial response) or ≥50% reduction (optimal effect) as dichotomous variables (yes/no; n, %), and/or the absence of headache within the first hour after the procedure.","definition_or_measurement_approach":"Headache reduction measured with the Numerical Pain Rating Scale (NPRS) at 1 hour post-procedure; defined as ≥30% reduction (partial response) or ≥50% reduction (optimal effect) as dichotomous variables (yes/no; n, %) and/or absence of headache within the first hour after the procedure."}

Recruitment

Planned Sample Size
40
Recruitment Window Months
16
Consent Approach
Signed informed consent from the patient or their representative. Subject information and informed consent forms available in Spanish and Catalan (documents L1_SIS and ICF available in Spanish and Catalan).

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Spain

Earliest CTIS Part Ii Submission Date
12-05-2025
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
38
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Anna Ramos Pachón
Contact Person Email
aramosp@santpau.cat

Sponsor

Primary sponsor

Full Name
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Lidocaína B. Braun 20 mg/ml solución inyectable
Active Substance
LIDOCAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Marketing authorisation number 44792 (authorised in ES)
Maximum Dose
3 ml
Investigational Product Name
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Marketing authorisation number 58449 (authorised in ES)
Maximum Dose
3 ml

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