Using machine learning to predict migraine treatment effectiveness
A Pragmatic Observational Study to Investigate Machine Prescription as Compared to Treatment-as-usual in Adults Aged 18 Years or Older With Migraine
This study is testing whether machine learning can help predict which migraine treatments will work best for patients, making it easier for them to find relief.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06893874 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the ability of machine learning models to predict the effectiveness of migraine preventive treatments. It will identify sociodemographic, headache, and comorbidity features of migraine patients and measure headache days for four weeks before starting treatment. After treatment initiation, the study will compare the predicted treatment effects from the machine learning models to the actual observed effects over a 12-week period. The goal is to reduce the time it takes for patients to find effective migraine prevention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with episodic or chronic migraine who have recently started or are planning to start a migraine preventive.
Not a fit: Patients who have previously failed all six prophylactic treatments being researched or have secondary headache conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly shorten the time to effective migraine treatment for patients.
How similar studies have performed: While machine learning applications in healthcare are growing, this specific approach to predicting migraine treatment effectiveness is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Trondheim
- NTNU Norwegian University of Science and Technology — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Anker Stubberud — Norwegian University of Science and Technology
- Study coordinator: Anker Stubberud, PhD
- Email: anker.stubberud@ntnu.no
- Phone: +4745229174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.