Comparing 4 common medicines to prevent migraine attacks
Compares amitriptyline, flunarizine, topiramate and propranolol for preventing migraine in adults.
Plain-language title generated from the registry record
Registry title: Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
Key facts
- Where
- Barcelona, Canet de Mar, Castelldefels, Cornellà de Llobregat, Girona, L'Hospitalet de Llobregat, Lleida, Molins de Rei, Palau-solità i Plegamans, Reus, Sant Feliu de Llobregat, Santa Coloma de Queralt, and Tortosa, SpainSee the 19 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with migraine who are candidates for preventive treatment and have at least 4 migraine days a month.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Migraine with at least 4 migraine days per month, where preventive treatment is a candidate option. Chronic migraine is not included.
- Earlier treatment
- People already taking preventive migraine treatment cannot join.
Main reasons for not taking part
- Chronic migraine (more than 15 headache days per month, of which 8 are migraine days)
- No smartphone
- Pregnancy or expected pregnancy in the next 3 months, or breastfeeding
- Already taking preventive migraine treatment
- Absolute contraindication to one of the study drugs, for example heart block, major depression, epilepsy or severe liver or kidney disease
Read by machine on 9 November 2026.
Where in Spain
- CAP AlhambraBarcelona, SpainTaking people
- CAP La SagreraBarcelona, SpainTaking people
- Sant Martí de ProvençalsBarcelona, SpainTaking people
- CAP Canet de MarCanet de Mar, SpainTaking people
- CAP El CastellCastelldefels, SpainTaking people
- CAP Can MoritzCornellà de Llobregat, SpainTaking people
- CAP Cornellà de LlobregatCornellà de Llobregat, SpainTaking people
- CAP Dr. Martí i JuliàCornellà de Llobregat, SpainTaking people
- CAP Sant IldefonsCornellà de Llobregat, SpainTaking people
- CAP Santa ClaraGirona, SpainTaking people
- CAP Amadeu TornerL'Hospitalet de Llobregat, SpainTaking people
- CAP La FloridaL'Hospitalet de Llobregat, SpainTaking people
- CAP Balafia-Pardinyes-Secà de Sant PereLleida, SpainTaking people
- CAP La GranjaMolins de Rei, SpainTaking people
- CAP Palau-Solità i PlegamansPalau-solità i Plegamans, SpainTaking people
- CAP Horts de MiróReus, SpainTaking people
- CAP RamblaSant Feliu de Llobregat, SpainTaking people
- CAP Santa Coloma de QueraltSanta Coloma de Queralt, SpainTaking people
- CAP El Temple - Tortosa EstTortosa, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Trial code
- NCT06499116EU 2024-513597-22-00
- Record updated
- 12 July 2024
- Original description
This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.Read full original descriptionShow less
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]
This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.
Inclusion: Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial.
Exclusion: People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis; People who, in the opinion of the clinician, have an absolute contraindication to one of the study drugs or who cannot perform the trial procedures:; Hypersensitivity to any of the study drugs / Heart block or severe bradycardia / Concomitant treatment with verapamil or diltiazem / Active cardiovascular pathology (recent heart attack, angina, Raynaud's phenomenon) / Major depression or active treatment with antidepressants (including monoamine oxidase inhibitors and St. John's wort) / Other psychiatric illnesses or active treatment with antipsychotics or lithium / Severe liver disease or kidney failure / Parkinson's disease or other extrapyramidal disorders / Epilepsy (diagnosis and/or active treatment) / Any other contraindication that, in the opinion of the clinician, prevents participation in the clinical trial; People diagnosed with migraine who are not candidates for preventive migraine treatment; People diagnosed with chronic migraine (>15 days of headache per month, of which 8 are monthly migraine days); Not having a smartphone; Simultaneous participation in another clinical trial; Pregnancy or expected pregnancy during the next 3 months; Lactation; People with migraine who already receive preventive treatment.