Status:
RECRUITING
A Pragmatic Trial of Machine Prescription for Migraine
Lead Sponsor:
Norwegian University of Science and Technology
Conditions:
Migraine
Eligibility:
All Genders
18-99 years
Brief Summary
The purpose of this study is to estimate the ability of ML models to predict the effect of migraine preventives. This will be achieved by first identifying sociodemographic, headache and comorbidity f...
Detailed Description
Rationale As the pathophysiology of migraine is complex, the treatment responses of different migraine preventives are highly heterogeneous. Therefore, migraine patients often try out more than one pr...
Eligibility Criteria
Inclusion
- Aged 18 years or older at trial entry. Episodic or chronic migraine with or without aura as per ICHD-3 criteria. Onset of migraine before age 50 years. History of at least 4 days of migraine in the 4-week baseline period based on retrospective or prospective headache diary assessment or subject recall.
- Having recently (within last 4 weeks) started or planning to start a migraine preventive.
- Signed and dated informed consent.
Exclusion
- Subject is concurrently using a migraine preventive that is not the drug under investigation.
- Subjects who have previously failed all six of the prophylactic treatments we are researching.
- Subjects diagnosed with trigeminal autonomic cephalalgias or facial neuralgias. Subjects with secondary headache conditions (except for medication overuse headache according to the ICHD-3).
- Subjects taking opioids (\>3 days per month) or barbiturates at the time of screening.
- Alcohol overuse or illicit drug use. Subjects participating in another clinical investigation.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06893874
Start Date
February 1 2025
End Date
December 31 2026
Last Update
March 25 2025
Active Locations (1)
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1
NTNU Norwegian University of Science and Technology
Trondheim, Norway, 7030