A Pragmatic Trial of Machine Prescription for Migraine

NCT06893874 | Recruiting

• 1 other identifier: 2726471
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Prediction of treatment effect

  The primary endpoint is to investigate the machine prescription models' ability to predict treatment effect of migraine preventives. To assess this, there will be one binary label of effect versus no effect for each preventive (if a participant has not tried a preventive, the instance will be categorized as missing). The three models will then be applied to the analysis sets, and their label predictions will be compared to the true labels, in a sense using the whole analysis sets as traditional machine learning test sets. The best performing model according to ROC-AUC will be reported.

  12 weeks

Secondary Outcomes (3)

• Time-to-treatment response

  12 weeks

• Rate of successful first therapy

  12 weeks

• External validity

  12 weeks

Other Outcomes (3)

• Comparison of models

  12 weeks

• Ensemble models

  12 weeks

• New models

  12 weeks

Interventions

Preventive migraine treatment OTHER

Participants will be observed while receiving treatment-as-usual for their migraine by their treating physician

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adult participants, aged 18 years or older, with episodic or chronic migraine according to ICHD-3 criteria.

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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

NTNU Norwegian University of Science and Technology

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anker Stubberud

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anker Stubberud, PhD

CONTACT

+4745229174; anker.stubberud@ntnu.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)