Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care

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 Criteria:

- 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 Criteria:

• 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.
• 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