Status:
COMPLETED
New-onset Severe Headache After Covid-19 Vaccine
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
St. Olavs Hospital
University Hospital, Akershus
Conditions:
Headache
Migraine
Eligibility:
All Genders
18+ years
Brief 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 t...
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 ...
Eligibility Criteria
Inclusion
- IInclusion 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).
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05235776
Start Date
January 1 2022
End Date
December 31 2023
Last Update
July 3 2024
Active Locations (10)
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1
Medi3
Ålesund, Norway
2
Hodepineklinikkken Bergen
Bergen, Norway
3
Anub Mathew Thomas
Drammen, Norway
4
Helsa Fonna Trust
Haugesund, Norway