RECRUITINGOBSERVATIONAL

A Pragmatic Trial of Machine Prescription for Migraine

A Pragmatic Observational Study to Investigate Machine Prescription as Compared to Treatment-as-usual in Adults Aged 18 Years or Older With Migraine

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

Preventive migraine treatment

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

Locations (1)

NTNU Norwegian University of Science and Technology

Trondheim, Norway