HeadacheCovaxHEADNCT05235776
New-onset Severe Headache After Covid-19 Vaccine
An observational study of Headache and Migraine, run by Oslo University Hospital at 10 sites in Norway.
Trial summary
Hypotheses: 1. Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals. 2. Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- observation
- How many people
- 63 participants
- Where
- 10 sitesNorway
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Cohort study of patients with new-onset severe headache after Covid-19 vaccine. Patients referred to the participating headache clinics for severe headache after Covid vaccine will be invited to participate in the study. The invitation will be given in conjunction with their visit to the headache specialist. Patients already diagnosed and treated for severe headache after Covid vaccine will be invited to participate during control visits at the participating centres. After written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. Further information will be collected prospectively. For newly diagnosed patients all information will be collected prospectively. Blood samples will be drawn to assess immunological mechanisms
Who may be able to join
- Informed written consent signed by the patient.
Who cannot join
- Patients not available for follow-up assessments (e.g. non-resident).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Norway10 sites
Medi3
Ålesund
Hodepineklinikkken Bergen
Bergen
Anub Mathew Thomas
Drammen
Helsa Fonna Trust
Haugesund
Møre og Romsdal Hospital Trust
Molde
Kristina Devik
Namsos
Oslo University Hospital
Oslo, 0424
Hodeverket
Sandnes
Sandvika Nevrosenter
Sandvika
St Olav University Hospital
Trondheim
About this study
Hypotheses:
- Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals.
- Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines.
- Biomarkers in blood and CSF and imaging findings can be used to assess severe new-onset headache after Covid-19 vaccines.
Read more
The main aim of the project is to describe the characteristics of severe new-onset headache after Covid vaccine and the treatment effects.
Secondary aim:
- Investigate potential mechanisms and analyse biomarkers to predict treatment effects.
- To assess at baseline and 6-month follow-up the rate of brain MRI pathology.
- To assess the change xof brain 18F-FDG PET metabolism from baseline and 6-month follow-up
- To assess the levels of brain specific biomarkers
- To assess the level of blood specific biomarkers
Duration of Study participation:
- Enrollment: 24 months
- Follow-up: at 3 and 6 months after inclusion. For those with continued severe headache regular 3-month controls are planned during the study.
Total study duration 24 months
Read the detailed description
Study Design: Prospective observational multi-center study
Cohort study of patients with new-onset severe headache after Covid-19 vaccine. Patients referred to the participating headache clinics for severe headache after Covid vaccine will be invited to participate in the study. The invitation will be given in conjunction with their visit to the headache specialist. Patients already diagnosed and treated for severe headache after Covid vaccine will be invited to participate during control visits at the participating centres. After written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. Further information will be collected prospectively. For newly diagnosed patients all information will be collected prospectively. Blood samples will be drawn to assess immunological mechanisms.
Inclusion criteria:
- Patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after Covid vaccination and has not resolved within 3 weeks.
- Inclusion within 12 months after symptom onset.
- Informed written consent signed by the patient.
Exclusion criteria:
- Patients not available for follow-up assessments (e.g. non-resident).
- Being tested
- observation
- Medical subject headings
- Headache, Migraine Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of the of new onset headache after Covid vaccination
qualitative description
Measured: at inclusion
Characteristics of the of new onset headache after Covid vaccination
qualitative description
Measured: 6 months
Secondary outcomes (11)
Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
number of days
Measured: at inclusion
Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
number of days
Measured: at 6 months
Headache intensity (0-3 scale) on days with headache at baseline
Headache intensity, number
Measured: at inclusion
Duration of new onset headache after Covid vaccination at baseline
number of hours
Measured: at inclusion
Duration of new onset headache after Covid vaccination at 6 months follow-up
number of hours
Measured: at 6 months
The six item Headache Impact Test (HIT-6) score at baseline
HIT-6 score
Measured: at inclusion
The six item Headache Impact Test (HIT-6) score at 6 months follow-up
HIT-6 score
Measured: at 6 months
The rate of brain MRI pathology at baseline
description of MRI pathology
Measured: at inclusion
The change of brain 18F-FDG PET/CT metabolism
description of brain 18F-FDG PET/CT metabolism
Measured: 6 months
The levels of brain specific biomarkers
The levels of brain specific biomarkers
Measured: at inclusion
The level of blood specific biomarkers
The levels of brain specific biomarkers
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital, Akershus, Vestre Viken Hospital Trust, Hodepineklinikken Bergen, Molde Hospital, Namsos Hospital, Medi3, Oslo Hodepinesenter, Sandvika Nevrosenter
- Responsible party
- Principal investigator, Anne Hege Aamodt, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235776
- Sponsor's protocol ID
- 351097
- Acronym
- CovaxHEAD
- Status last verified
- Jul 2024
- First submitted
- 8 Feb 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aamodt AH, Ueland T, Boldingh M, Bezgal BE, Argren MB, Dunne CA, Otterdal K, Gregersen I, Bjerkeli V, Michelsen AE, Husoy A, Morsund AH, Devik K, Poole AC, Gjendemsjo KB, Schluter K, Mathisen SM, Aalstad-Johansen M, Skattor TH, Sonnervik J, Boye TB, Popperud TH, Hogestol EA, Harbo HF, Lund-Johansen F, Aukrust P, Tronvik E, Dahl TB, Halvorsen BE. Altered amyloid plasma profile in patients with disabling headaches after SARS-CoV-2 infection and vaccination. BMJ Neurol Open. 2025 Aug 26;7(2):e001013. doi: 10.1136/bmjno-2024-001013. eCollection 2025.
PubMed 40881041
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New-onset Severe Headache After Covid-19 Vaccine
- ClinicalTrials.gov ID
- NCT05235776
- Acronym / sponsor ID
- CovaxHEAD / 351097
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital, Akershus, Vestre Viken Hospital Trust, Hodepineklinikken Bergen, Molde Hospital, Namsos Hospital, Medi3, Oslo Hodepinesenter, Sandvika Nevrosenter
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Feb 2022 (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.
Hypotheses:
- Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals.
- Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines.
- Biomarkers in blood and CSF and imaging findings can be used to assess severe new-onset headache after Covid-19 vaccines.
The main aim of the project is to describe the characteristics of severe new-onset headache after Covid vaccine and the treatment effects.
Secondary aim:
- Investigate potential mechanisms and analyse biomarkers to predict treatment effects.
- To assess at baseline and 6-month follow-up the rate of brain MRI pathology.
- To assess the change xof brain 18F-FDG PET metabolism from baseline and 6-month follow-up
- To assess the levels of brain specific biomarkers
- To assess the level of blood specific biomarkers
Duration of Study participation:
- Enrollment: 24 months
- Follow-up: at 3 and 6 months after inclusion. For those with continued severe headache regular 3-month controls are planned during the study.
Total study duration 24 months
Detailed description
Study Design: Prospective observational multi-center study
Cohort study of patients with new-onset severe headache after Covid-19 vaccine. Patients referred to the participating headache clinics for severe headache after Covid vaccine will be invited to participate in the study. The invitation will be given in conjunction with their visit to the headache specialist. Patients already diagnosed and treated for severe headache after Covid vaccine will be invited to participate during control visits at the participating centres. After written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. Further information will be collected prospectively. For newly diagnosed patients all information will be collected prospectively. Blood samples will be drawn to assess immunological mechanisms.
Inclusion criteria:
- Patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after Covid vaccination and has not resolved within 3 weeks.
- Inclusion within 12 months after symptom onset.
- Informed written consent signed by the patient.
Exclusion criteria:
- Patients not available for follow-up assessments (e.g. non-resident).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort study of patients with new-onset severe headache after Covid-19 vaccine. Patients referred to the participating headache clinics for severe headache after Covid vaccine will be invited to participate in the study. The invitation will be given in conjunction with their visit to the headache specialist. Patients already diagnosed and treated for severe headache after Covid vaccine will be invited to participate during control visits at the participating centres. After written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. Further information will be collected prospectively. For newly diagnosed patients all information will be collected prospectively. Blood samples will be drawn to assess immunological mechanisms
Key inclusion criteria (1 listed)
- Informed written consent signed by the patient.
Key exclusion criteria (1 listed)
- Patients not available for follow-up assessments (e.g. non-resident).
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 |
|---|---|---|
| observationobservation | Other | – |
Primary outcome
Characteristics of the of new onset headache after Covid vaccination
Time frame: at inclusion
qualitative description
Characteristics of the of new onset headache after Covid vaccination
Time frame: 6 months
qualitative description
11 secondary outcomes
Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
Time frame: at inclusion
Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
Time frame: at 6 months
Headache intensity (0-3 scale) on days with headache at baseline
Time frame: at inclusion
Duration of new onset headache after Covid vaccination at baseline
Time frame: at inclusion
Duration of new onset headache after Covid vaccination at 6 months follow-up
Time frame: at 6 months
The six item Headache Impact Test (HIT-6) score at baseline
Time frame: at inclusion
The six item Headache Impact Test (HIT-6) score at 6 months follow-up
Time frame: at 6 months
The rate of brain MRI pathology at baseline
Time frame: at inclusion
The change of brain 18F-FDG PET/CT metabolism
Time frame: 6 months
The levels of brain specific biomarkers
Time frame: at inclusion
The level of blood specific biomarkers
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 40881041Aamodt AH, Ueland T, Boldingh M, Bezgal BE, Argren MB, Dunne CA, Otterdal K, Gregersen I, Bjerkeli V, Michelsen AE, Husoy A, Morsund AH, Devik K, Poole AC, Gjendemsjo KB, Schluter K, Mathisen SM, Aalstad-Johansen M, Skattor TH, Sonnervik J, Boye TB, Popperud TH, Hogestol EA, Harbo HF, Lund-Johansen F, Aukrust P, Tronvik E, Dahl TB, Halvorsen BE. Altered amyloid plasma profile in patients with disabling headaches after SARS-CoV-2 infection and vaccination. BMJ Neurol Open. 2025 Aug 26;7(2):e001013. doi: 10.1136/bmjno-2024-001013. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Migraine, run by Oslo University Hospital at 10 sites in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characteristics of the of new onset headache after Covid vaccination (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235776, which also lists 1 linked publication.
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 3 Jul 2024.