Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topiramate, Flunarizine, Amitriptyline, Propranolol.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]
Overview
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.
Interventions
- Drug Topiramate
Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h. - Drug Flunarizine
Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h. - Drug Amitriptyline
Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h. - Drug Propranolol
Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.
Primary outcome measures
- 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. [Time frame: 12 weeks]
Secondary outcome measures (11)
- Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline) [Time frame: 12 weeks]
- Evaluate effectiveness before completing the clinical trial [Time frame: 4, 8 and 12 weeks]
- Estimate the reduction in the intensity of migraine attacks [Time frame: 4, 8 and 12 weeks]
- Estimate the prevalence of symptoms associated with migraine [Time frame: 12 weeks]
- Evaluate adherence to preventive treatment [Time frame: 12 weeks]
- Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others). [Time frame: 4, 8 and 12 weeks]
- Evaluate reconsultation visits due to migraine attacks [Time frame: 4, 8 and 12 weeks]
- Evaluate improvement in quality of life and patient satisfaction [Time frame: 12 weeks]
- Analyze the differences between men and women regarding study drugs effectiveness. [Time frame: 4, 8 and 12 weeks]
- Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism. [Time frame: 12 weeks]
- Incidence of adverse events of the four drugs used in the preventive treatment of migraine . [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT06499116 · IJG-PREMI-2024 · 2024-513597-22-00