FLUNARIZINE HYDROCHLORIDE for Migraine

Inclusion criteria

• {"criterion_text":"- 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

• {"criterion_text":"- People diagnosed with migraine who are not candidates for preventive migraine treatment"}
• {"criterion_text":"- People diagnosed with chronic migraine (>15 days of headache per month, of which 8 are monthly migraine days)"}
• {"criterion_text":"- Not having a smartphone"}
• {"criterion_text":"- Simultaneous participation in another clinical trial"}
• {"criterion_text":"- Pregnancy or expected pregnancy during the next 3 months"}
• {"criterion_text":"- Lactation"}
• {"criterion_text":"- People with migraine who already receive preventive treatment."}
• {"criterion_text":"- People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis."}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.","definition_or_measurement_approach":"Change in the mean number of monthly migraine days (MMD) at 12 weeks compared to baseline."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of patients classified by percent change in mean monthly migraine days at 12 weeks with categories: <25% non-responders; 25-49% partial; 50-75% responders; >75% excellent responders."}
• {"endpoint_text":"- Change in mean number of MMDs at 4 and 8 weeks from baseline.","definition_or_measurement_approach":"Change in mean monthly migraine days at weeks 4 and 8 compared to baseline."}
• {"endpoint_text":"- Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.","definition_or_measurement_approach":"Change in mean number of moderate-to-severe monthly migraine days at weeks 4, 8, and 12 versus baseline."}
• {"endpoint_text":"- Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.","definition_or_measurement_approach":"Proportion of patients reporting associated symptoms (photophobia, phonophobia, nausea) at 12 weeks."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion adherent vs non-adherent at 12 weeks based on reported taking (yes/no) of the prescribed study treatment and dosage."}
• {"endpoint_text":"- Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.","definition_or_measurement_approach":"Change in mean number of symptomatic medications used at weeks 4, 8, and 12 compared to baseline."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Counts and types of reconsultations and number of medical tests related to migraine during the 12-week follow-up."}
• {"endpoint_text":"- Patients' Global Impression of Change (PGIC) scale at 12 weeks.","definition_or_measurement_approach":"PGIC score at 12 weeks from treatment start."}
• {"endpoint_text":"- Change in EQ-5D-5L questionnaire at 12 weeks from baseline.","definition_or_measurement_approach":"Change in EQ-5D-5L score at 12 weeks versus baseline."}
• {"endpoint_text":"- Change in HIT-6 questionnaire at 12 weeks from baseline.","definition_or_measurement_approach":"Change in HIT-6 score at 12 weeks versus baseline."}
• {"endpoint_text":"- Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.","definition_or_measurement_approach":"Change in number of lost productivity days (ILT), absenteeism and presenteeism at 12 weeks versus baseline."}
• {"endpoint_text":"- Adherence to treatment 6 months after the start of the trial.","definition_or_measurement_approach":"Proportion adherent to treatment assessed at 6 months after start."}
• {"endpoint_text":"- Switching or discontinuation of drug for preventive treatment after 6 months from the start of the trial.","definition_or_measurement_approach":"Count/proportion of participants who switch or discontinue preventive treatment at 6 months."}

Spain

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

21-07-2025

Processing Time Days

318

Number Of Sites

16

Number Of Participants

460

Primary sponsor

Full Name

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain