Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT06893874

A Pragmatic Trial of Machine Prescription for Migraine

Led by Norwegian University of Science and Technology · Updated on 2025-03-25

200

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Pragmatic Trial of Machine Prescription for Migraine

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older at trial entry
  • Diagnosed with episodic or chronic migraine with or without aura according to ICHD-3 criteria
  • Migraine onset before age 50 years
  • History of at least 4 migraine days in the 4-week baseline period based on headache diaries or recall
  • Recently started or planning to start a migraine preventive within the last 4 weeks
  • Signed and dated informed consent
Not Eligible

You will not qualify if you...

  • Currently using a migraine preventive medication that is not part of the study
  • Previously failed all six migraine preventive treatments being researched
  • Diagnosed with trigeminal autonomic cephalalgias or facial neuralgias
  • Having secondary headache conditions, except medication overuse headache
  • Taking opioids more than 3 days per month or barbiturates at screening
  • Alcohol overuse or illicit drug use
  • Participating in another clinical investigation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NTNU Norwegian University of Science and Technology

Trondheim, Norway, 7030

Actively Recruiting

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Research Team

A

Anker Stubberud, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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