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

Phase 4Not Yet RecruitingNCT06499116

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina460 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

460

Conditions

Migraine

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.

Time frame: 12 weeks

Secondary Outcomes

Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline)

Proportion of patients responding at 12 weeks from start of treatment; \<25% change in mean number of MMD: non-responders, 25-49%: partial responders, 50-75%: responders, \>75%: excellent responders.

Time frame: 12 weeks

Evaluate effectiveness before completing the clinical trial

Change in mean number of MMDs at 4 and 8 weeks from baseline.

Time frame: 4, 8 and 12 weeks

Estimate the reduction in the intensity of migraine attacks

Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.

Time frame: 4, 8 and 12 weeks

Estimate the prevalence of symptoms associated with migraine

Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.

Time frame: 12 weeks

Evaluate adherence to preventive treatment

Proportion of adherent and non-adherent patients (according to taking \[yes/no\] of the study treatment with the prescribed dosage) at 12 weeks from the start of treatment.

Time frame: 12 weeks

Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others).

Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.

Time frame: 4, 8 and 12 weeks

Evaluate reconsultation visits due to migraine attacks

Reconsultations: Type of consultation (PCC, PC emergency, hospital, hospital emergency). Number of consultations after 12 weeks from the start. Number of medical tests performed relacionadas con la migraña.

Time frame: 4, 8 and 12 weeks

Evaluate improvement in quality of life and patient satisfaction

Change in EQ-5D-5L questionnaire at 12 weeks from baseline. Including Visual Analogue Scale (0-100). Lower scores means worse health condition.

Time frame: 12 weeks

Analyze the differences between men and women regarding study drugs effectiveness.

Result comparison change in mean number of MMDs adjusted by sex

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.

Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.

Time frame: 12 weeks

Incidence of adverse events of the four drugs used in the preventive treatment of migraine .

Number of adverse events

Time frame: 12 weeks

Central Contacts

Maria Giner-Soriano

CONTACT

+34 93 482 4110 mginer@idiapjgol.info

Ana Garcia-Sangenis

CONTACT

+34 93 482 4651 agarcia@idiapjgol.org