Overview
Sponsor-declared trial summary
Reversible cerebral vasoconstriction syndrome
The main objective of the study is to test the hypothesis that the addition of a calcium channel blocker on top of standard care can reduce the frequency of recurrent headache attacks in patients diagnosed with reversible cerebral vasoconstriction syndrome without parenchymal lesions or subarachnoid hemorrhage on CT/MR…
Key facts
- Sponsor
- HUS Helsinki University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-05-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- HUS: Helsinki University Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective of the study is to test the hypothesis that the addition of a calcium channel blocker on top of standard care can reduce the frequency of recurrent headache attacks in patients diagnosed with reversible cerebral vasoconstriction syndrome without parenchymal lesions or subarachnoid hemorrhage on CT/MRI.
Conditions and MedDRA coding
Reversible cerebral vasoconstriction syndrome
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504547-14-00 | Calcium Channel blocker in treatment of reversible cerebral vasoconstriction syndrome: a double-blind, randomized, placebo-controlled trial. | HUS Helsinki University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥ 18 years at entry
- Thunderclap headache (reaching peak intensity within ≤1 minute) or severe recurrent headache
- Cerebral vasoconstriction on imaging in at least 2 different arteries or cerebral vasoconstriction in one artery and typical clinical picture with thunderclap headache
- Absence of acute or subacute infarction, hemorrhage or findings suggesting posterior reversible encephalopathy syndrome on CT/MRI.
- Absence of aneurysmal subarachnoid hemorrhage (SAH)
Exclusion criteria 5
- Ongoing usage of calcium channel blockers before the index event
- Parenchymal lesions on CT/MRI (ischemic lesions, intracerebral hemorrhage, posterior reversible encephalopathy syndrome)
- Subarachnoid hemorrhage on CT/MRI
- Clinical suspicion of PACNS or other CNS vasculitis
- An abnormal cerebrospinal fluid (CSF) finding, if a lumbar puncture is performed.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Frequency of recurring headache
Secondary endpoints 3
- Occurrence of any radiological complication (ischemic stroke, SAH, ICH, PRES) on computed tomography or magnetic resonance tomography
- Radiological reversibility of the vasoconstriction on the follow-up CTA/MRA
- Intensity of recurring headache attacks
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB05467MIG · Substance
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS Helsinki University Hospital
- Sponsor organisation
- HUS Helsinki University Hospital
- Address
- Haartmaninkatu 4
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS Helsinki University Hospital
- Contact name
- Sami Curtze
Public contact point
- Organisation
- HUS Helsinki University Hospital
- Contact name
- Sami Curtze
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clinical Trial Protocol | 3 |
| Recruitment arrangements (for publication) | Recruitment_arrangements | 3 |
| Recruitment arrangements (for publication) | Recruitmentarrangementsv31 | 2 |
| Subject information and informed consent form (for publication) | Suostumusasiakirja_CACH-RECEVAv31fi | 3 |
| Subject information and informed consent form (for publication) | Suostumusasiakirja_CACH-RECEVAv31sv | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of product characteristics | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Finland | Acceptable with conditions 2025-04-29
|
2025-05-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-03 | Finland | Acceptable 2026-04-10
|
2026-04-13 |