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

ConditionMigraine
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Topiramate

    Drug

    Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.

  • Flunarizine

    Drug

    Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.

  • Amitriptyline

    Drug

    Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.

  • Propranolol

    Drug

    Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.

Treatment groups

460 Participants
are divided into 4 treatment groups
Group A: TopiramateExperimental treatment 1 intervention
Group B: FlunarizineExperimental treatment 1 intervention
Group C: AmitriptylineExperimental treatment 1 intervention
Group D: PropranololActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Lead sponsor

Institut Català de la Salut

Collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: