A Pragmatic Trial of Machine Prescription for Migraine
Launched by NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · Mar 18, 2025
Trial Information
Current as of April 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well machine learning models can predict the effectiveness of migraine preventive treatments. Researchers will first look at the background and health details of participants, including how often they experience migraines. Participants will keep track of their headache days for four weeks before starting a new migraine preventive treatment. After beginning the treatment, they will continue to record their headache days for up to 12 weeks. If the treatment successfully reduces headache days by 50% or more, it's considered effective. The study will then compare the actual results with what the models predicted.
To be eligible for this trial, participants need to be 18 years or older and have been diagnosed with episodic or chronic migraines. They should have experienced at least four migraine days in the month leading up to the trial and must be starting a new preventive treatment. It's important to note that individuals currently using other migraine preventives or those with specific types of headaches will not be eligible. If you join this study, you can expect to contribute valuable information that could help improve migraine treatment for others in the future.
Gender
ALL
Eligibility 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.
About Norwegian University Of Science And Technology
The Norwegian University of Science and Technology (NTNU) is a leading research institution dedicated to advancing knowledge and innovation in various scientific fields. Renowned for its commitment to interdisciplinary collaboration, NTNU plays a pivotal role in addressing global health challenges through rigorous clinical trials and research initiatives. The university's emphasis on cutting-edge technology and its strong partnerships with healthcare sectors position it as a key player in translational research, ensuring that findings contribute effectively to improving public health and patient care. With a focus on ethical standards and scientific integrity, NTNU is dedicated to fostering advancements that enhance the quality of life and health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Trondheim, , Norway
Patients applied
Trial Officials
Anker Stubberud
Principal Investigator
Norwegian University of Science and Technology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported