Comparison of the effectiveness of first-line preventive treatment of migraine in primary care: a pragmatic clinical trial [PREMI study]

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol12 sites in 1 country460 target enrollmentOctober 3, 2024

Drugs1-NAPHTHALEN-1-YLOXY-3-(PROPAN-2-YLAMINO)PROPAN-2-OL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIIDE PROPRANOLOLI HYDROCHLORIDUM PROPRANOLOL AMITRIPTYLINE TOPIRAMATE FLUNARIZINE

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Institut Universitari D Investigacio En Atencion Primaria Jordi Gol
Enrollment: 460
Locations: 12
Primary Endpoint: Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.

Registry

euclinicaltrials.eu

Start Date

October 3, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Responsible Party

Principal Investigator

Maria Giner-Soriano

Scientific

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

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
•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

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

Secondary Outcomes

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.
Change in mean number of MMDs at 4 and 8 weeks from baseline.
Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.
Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.
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.
Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.
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.
Patients' Global Impression of Change (PGIC) scale at 12 weeks.
Change in EQ-5D-5L questionnaire at 12 weeks from baseline.
Change in HIT-6 questionnaire at 12 weeks from baseline.
Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.
Adherence to treatment 6 months after the start of the trial.
Switching or discontinuation of drug for preventive treatment after 6 months from the start of the trial.