Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborating Sponsors:

Institut Català de la Salut

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

Conditions:

Migraine

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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, topi...

Eligibility Criteria

Inclusion

  • \- 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

  • 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

Key Trial Info

Start Date :

October 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

460 Patients enrolled

Trial Details

Trial ID

NCT06499116

Start Date

October 1 2024

End Date

December 1 2026

Last Update

July 12 2024

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