Clinical trial to compare the effectiveness of migraine’s preventive treatments in primary care
- Conditions
- Migraine
- Registration Number
- 2024-513597-22-00
- Lead Sponsor
- Institut Universitari D Investigacio En Atencion Primaria Jordi Gol
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 460
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline. Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.
- Secondary Outcome Measures
Name Time Method 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. 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. 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. 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 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. 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. 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. 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. Patients' Global Impression of Change (PGIC) scale at 12 weeks.
Change in EQ-5D-5L questionnaire at 12 weeks from baseline. Change in EQ-5D-5L questionnaire at 12 weeks from baseline.
Change in HIT-6 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. 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. 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. Switching or discontinuation of drug for preventive treatment after 6 months from the start of the trial.
Trial Locations
- Locations (12)
Sant Martí de Provençals
🇪🇸Barcelona, Spain
CAP Cornellà de Llobregat
🇪🇸Cornellà de Llobregat, Spain
CAP El Temple - Tortosa Est
🇪🇸Tortosa, Spain
CAP Dr. Martí i Julià
🇪🇸Cornellà de Llobregat, Spain
CAP Sant Ildefons
🇪🇸Cornellà de Llobregat, Spain
CAP Santa Coloma de Queralt
🇪🇸Santa Coloma de Queralt, Spain
CAP Rambla
🇪🇸Sant Feliu de Llobregat, Spain
CAP Can Moritz
🇪🇸Cornellà de Llobregat, Spain
CAP Balafia-Pardinyes-Secà de Sant Pere
🇪🇸Lleida, Spain
CAP Canet de Mar
🇪🇸Canet de Mar, Spain
Scroll for more (2 remaining)Sant Martí de Provençals🇪🇸Barcelona, SpainCarme Gisbert RevillaSite contact+34933070812mariacarmengisbert@gencat.cat