Clinical trial NCT06499116: Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
Official title: Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Monthly Migraine Days (MMD)
Preventive treatment
Primary care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2024-07-12
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effectiveness of the most frequently used drugs in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.
timeFrame: 12 weeks
Secondary outcomes:
measure: Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline)
timeFrame: 12 weeks
measure: Evaluate effectiveness before completing the clinical trial
timeFrame: 4, 8 and 12 weeks
measure: Estimate the reduction in the intensity of migraine attacks
timeFrame: 4, 8 and 12 weeks
measure: Estimate the prevalence of symptoms associated with migraine
timeFrame: 12 weeks
measure: Evaluate adherence to preventive treatment
timeFrame: 12 weeks
measure: Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others).
timeFrame: 4, 8 and 12 weeks
measure: Evaluate reconsultation visits due to migraine attacks
timeFrame: 4, 8 and 12 weeks
measure: Evaluate improvement in quality of life and patient satisfaction
timeFrame: 12 weeks
measure: Analyze the differences between men and women regarding study drugs effectiveness.
timeFrame: 4, 8 and 12 weeks
measure: Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism.
timeFrame: 12 weeks
measure: Incidence of adverse events of the four drugs used in the preventive treatment of migraine .
timeFrame: 12 weeks
Other outcomes:
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