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

Официальное название

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]

Обзор

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.

Вмешательства

• Препарат Topiramate
  Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.
• Препарат Flunarizine
  Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.
• Препарат Amitriptyline
  Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.
• Препарат Propranolol
  Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.

Первичные конечные точки

• 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. [Срок оценки: 12 weeks]

Вторичные конечные точки (11)

• Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline) [Срок оценки: 12 weeks]
• Evaluate effectiveness before completing the clinical trial [Срок оценки: 4, 8 and 12 weeks]
• Estimate the reduction in the intensity of migraine attacks [Срок оценки: 4, 8 and 12 weeks]
• Estimate the prevalence of symptoms associated with migraine [Срок оценки: 12 weeks]
• Evaluate adherence to preventive treatment [Срок оценки: 12 weeks]
• Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others). [Срок оценки: 4, 8 and 12 weeks]
• Evaluate reconsultation visits due to migraine attacks [Срок оценки: 4, 8 and 12 weeks]
• Evaluate improvement in quality of life and patient satisfaction [Срок оценки: 12 weeks]
• Analyze the differences between men and women regarding study drugs effectiveness. [Срок оценки: 4, 8 and 12 weeks]
• Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism. [Срок оценки: 12 weeks]
• Incidence of adverse events of the four drugs used in the preventive treatment of migraine . [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Giner-Soriano M, Morros R, Monfa R, Ouchi D, Fernandez-Garcia S, Vedia C, Bonet Monne S, Calvo Martinez EM, Copetti Fanlo S, Morollon N, Belvis Nieto R, Delgado-Espinoza CE, Garcia-Sangenis A. Comparison of the effectiveness of first-line preventive treatment of migraine in primary care: study protocol for a pragmatic clinical trial (PREMI study). Trials. 2025 Aug 26;26(1):311. doi: 10.1186/s13063 PMID 40859286

Идентификаторы

NCT: NCT06499116 · IJG-PREMI-2024 · 2024-513597-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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