Clinical trial • Phase IV • Neurology

AMLODIPINE for Reversible cerebral vasoconstriction syndrome

Phase IV trial of AMLODIPINE for Reversible cerebral vasoconstriction syndrome.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Reversible cerebral vasoconstriction syndrome
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-12-2024
First CTIS Authorization Date
05-05-2025

Trial design

Randomised, placebo control; active investigational product: amlodipine (oral; maximum daily dose reported as 10 mg) Phase IV trial across 1 site in Finland.

Randomised
Yes
Comparator
Placebo control; active investigational product: AMLODIPINE (oral; maximum daily dose reported as 10 mg)
Target Sample Size
100

Eligibility

Recruits 100 Vulnerable population not selected (isVulnerablePopulationSelected: false); participants must be Age ≥ 18. Subject information and informed consent forms are provided (documents: Suostumusasiakirja_CACH-RECEVAv31fi, Suostumusasiakirja_CACH-RECEVAv31sv)..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false); participants must be Age ≥ 18. Subject information and informed consent forms are provided (documents: Suostumusasiakirja_CACH-RECEVAv31fi, Suostumusasiakirja_CACH-RECEVAv31sv).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years at entry\n- Thunderclap headache (reaching peak intensity within ≤1 minute) or severe recurrent headache\n- Cerebral vasoconstriction on imaging in at least 2 different arteries or cerebral vasoconstriction in one artery and typical clinical picture with thunderclap headache\n- Absence of acute or subacute infarction, hemorrhage or findings suggesting posterior reversible encephalopathy syndrome on CT/MRI.\n- Absence of aneurysmal subarachnoid hemorrhage (SAH)"}

Exclusion criteria

  • {"criterion_text":"- Ongoing usage of calcium channel blockers before the index event\n- Parenchymal lesions on CT/MRI (ischemic lesions, intracerebral hemorrhage, posterior reversible encephalopathy syndrome)\n- Subarachnoid hemorrhage on CT/MRI\n- Clinical suspicion of PACNS or other CNS vasculitis\n- An abnormal cerebrospinal fluid (CSF) finding, if a lumbar puncture is performed."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Frequency of recurring headache","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Occurrence of any radiological complication (ischemic stroke, SAH, ICH, PRES) on computed tomography or magnetic resonance tomography","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Radiological reversibility of the vasoconstriction on the follow-up CTA/MRA","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Intensity of recurring headache attacks","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
100
Recruitment Window Months
94
Consent Approach
Informed consent provided by adult participants (trial inclusion requires Age ≥ 18). Subject information and informed consent forms available (documents: Suostumusasiakirja_CACH-RECEVAv31fi [Finnish], Suostumusasiakirja_CACH-RECEVAv31sv [Swedish]). No vulnerable population selection indicated.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Finland

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
479
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Helsinki University Central Hospital
Department Name
Department of Neurology
Principal Investigator Name
Sami Curtze
Principal Investigator Email
sami.curtze@hus.fi
Contact Person Name
Sami Curtze
Contact Person Email
sami.curtze@hus.fi
Number Of Participants
100

Sponsor

Primary sponsor

Full Name
HUS Helsinki University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
AMLODIPINE
Active Substance
AMLODIPINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised / marketing approved (trial described as Phase 4 study of a medication that has received regulatory approval)
Maximum Dose
10 mg daily
Combination Treatment
Yes

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