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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase: Not yet enrolling; Phase 4

Conditions: Migraine

Treatments: Drug: Flunarizine; Drug: Amitriptyline; Drug: Propranolol; Drug: Topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT06499116

2024-513597-22-00 (EU Trial (CTIS) Number)

IJG-PREMI-2024

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 4 patient groups

Topiramate

Experimental group

Description:

25-100 mg/12h, V.O., during 12 weeks

Treatment:

Drug: Topiramate

Flunarizine

Experimental group

Description:

2,5-10 mg/24h, V.O., during 12 weeks

Treatment:

Drug: Flunarizine

Amitriptyline

Experimental group

Description:

10-75 mg/24h, V.O., during 12 weeks

Treatment:

Drug: Amitriptyline

Propranolol

Active Comparator group

Description:

20-120 mg/12h, V.O., during 12 weeks

Treatment:

Drug: Propranolol