NCT06893874 A Pragmatic Trial of Machine Prescription for Migraine
| NCT ID | NCT06893874 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Norwegian University of Science and Technology |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Anker Stubberud
PRINCIPAL INVESTIGATOR
Norwegian University of Science and Technology
Frequently Asked Questions
Who can join the NCT06893874 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06893874 currently recruiting?
Yes, NCT06893874 is actively recruiting participants. Contact the research team at anker.stubberud@ntnu.no for enrollment information.
Where is the NCT06893874 trial being conducted?
This trial is being conducted at Trondheim, Norway.
Who is sponsoring the NCT06893874 clinical trial?
NCT06893874 is sponsored by Norwegian University of Science and Technology. The principal investigator is Anker Stubberud at Norwegian University of Science and Technology. The trial plans to enroll 200 participants.
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