A Pragmatic Trial of Machine Prescription for Migraine

Recruiting now

Conditions studied: Migraine

In brief

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 features of migraine patients. Headache days will then be measured for 4 weeks before starting a migraine preventive, and this will be compared to the number of headache days in the first 12 weeks (divided into 28-day periods) after starting treatment. The preventive is regarded as effective if there is a 50% or greater reduction in monthly headache days. After observation of the treatment period, the ML models will use the sociodemographic, headache and comorbidity features, captured before treatment was initiated, to predict treatment effect for all preventives in each participant. These predicted treatment effects will be compared to the actual treatment effects that were observed.

Key facts

Study ID

NCT06893874

Run by

Norwegian University of Science and Technology

People needed

200

Starts

2025-02-01

Expected to finish

2026-12-31

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NTNU Norwegian University of Science and Technology — Trondheim, Norway (enrolling)

Full record on ClinicalTrials.gov

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