A Pragmatic Trial of Machine Prescription for Migraine

Launched by NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well machine learning models can predict the effectiveness of migraine preventive treatments. Researchers will first look at the background and health details of participants, including how often they experience migraines. Participants will keep track of their headache days for four weeks before starting a new migraine preventive treatment. After beginning the treatment, they will continue to record their headache days for up to 12 weeks. If the treatment successfully reduces headache days by 50% or more, it's considered effective. The study will then compare the actual results with what the models predicted.

To be eligible for this trial, participants need to be 18 years or older and have been diagnosed with episodic or chronic migraines. They should have experienced at least four migraine days in the month leading up to the trial and must be starting a new preventive treatment. It's important to note that individuals currently using other migraine preventives or those with specific types of headaches will not be eligible. If you join this study, you can expect to contribute valuable information that could help improve migraine treatment for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.