Cluster HeadachePhase 4SEVANCT04406259
Atrioventricular Block and Cluster Headache (SEVA)
A Phase 4 study testing Verapamil in people with Cluster Headache, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Verapamil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Nov 2020to 5 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient 18 years old, and older
- patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias)
- patients affiliated to the social security
- patient that has given his full written consent to participate in the study
- female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study
Who cannot join
- patient presenting contraindications to the use of verapamil
- patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine.
- patient under justicial protection
- patient breastfeeding, or pregnant
- patient suffering from a neuromuscular transmisson disease
- patient with a pacemaker
Trial locations and contacts
2 sites in 1 country.
France2 sites
AP-HP Hôpital la Timone
Marseille, 13005
CHU de Nice
Nice, CHUN, 06003
About this study
Official title: Atrioventricular Block and Cluster Headache
Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.
- Conditions
- Cluster Headache
- Being tested
- Verapamil
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Patients in groupe A require verapamil initiation as a preventive treatment and patients in group B are patients already undergoing a verapamil treatment for their Cluster Headache.
The doses of verapamil are increased for the patients in group A, after a clinical examination an electrocardiogram, and a blood test.
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Other | administration of verapamil to treat cluster headache Receives: Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
Occurrence of the ratio of patients presenting a first degree atrioventricular block
Measured: 27 months
Secondary outcomes (3)
Description of the different atrioventricular conduction abnormities and their incidence
Study of ECG results
Measured: 27 months
Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram
Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit
Measured: 27 months
Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.
The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start2 Nov 2020
- Primary completion5 Sep 2025
- Study completion5 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective cohort, interventional , multicentric study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406259
- Sponsor's protocol ID
- 18-API-03
- Acronym
- SEVA
- Status last verified
- Nov 2025
- First submitted
- 14 May 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing plan ahs been established
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrioventricular Block and Cluster Headache
- ClinicalTrials.gov ID
- NCT04406259
- Acronym / sponsor ID
- SEVA / 18-API-03
- Conditions
- Cluster Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2027 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort, interventional , multicentric study
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Other | Drug: Verapamiladministration of verapamil to treat cluster headache |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient 18 years old, and older
- patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias)
- patients affiliated to the social security
- patient that has given his full written consent to participate in the study
- female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study
Key exclusion criteria (6 listed)
- patient presenting contraindications to the use of verapamil
- patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine.
- patient under justicial protection
- patient breastfeeding, or pregnant
- patient suffering from a neuromuscular transmisson disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerapamilPatients in groupe A require verapamil initiation as a preventive treatment and patients in group B are patients already undergoing a verapamil treatment for their Cluster Headache. The doses of verapamil are increased for the patients in group A, after a clinical examination an electrocardiogram, and a blood test. | Drug | Verapamil |
Primary outcome
Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
Time frame: 27 months
Occurrence of the ratio of patients presenting a first degree atrioventricular block
3 secondary outcomes
Description of the different atrioventricular conduction abnormities and their incidence
Time frame: 27 months
Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram
Time frame: 27 months
Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.
Time frame: 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. No data sharing plan ahs been established
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Verapamil in people with Cluster Headache, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache. (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.