NCT06893874Completed
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 169 (actual)
- First submitted
- 18 Mar 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 17 Sept 2026
- Lead sponsor
- Norwegian University of Science and Technology
- Diseases
- Migraine
- NCT number
- NCT06893874
What you commit to
- Study type: Observational
- Participants enrolled: 169
- From 1 Feb 2025 to the primary completion date, 17 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Alcohol overuse or illicit drug use. Subjects participating in another clinical investigation.
Other illness
- Subjects diagnosed with trigeminal autonomic cephalalgias or facial neuralgias. Subjects with secondary headache conditions (except for medication overuse headache according to the ICHD-3).
Other
- Subjects taking opioids (\>3 days per month) or barbiturates at the time of screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NTNU Norwegian University of Science and Technology Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.