Prevention of migraine attacks in pediatric population.
Conditions
Interventions
Trade Name: FLURPAX cápsulas
Pharmaceutical Form: Capsule
INN or Proposed INN: FLUNARIZINA DIHIDROCLORURO
CAS Number: 30484-77-6
Other descriptive name: FLUNARIZINE DIHYDROCHLORIDE
Concentration unit:
Sponsors
CAIBER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients aged from 7 to 14 years attended at Neuropediatrics outpatient clinic of the participating centers and diagnosed with migraine according to IHS criteria. -Patients who had at least two migraine episodes per week in the last month. -Informed consent signed (parent / legal representative and the patient in case of children aged 12-14 years). -Assent of the child in case of children aged 7-11 years Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Previous treatment with flunarizine. ·Previous participation in other migraine clinical trials. ·Patients with lactose intolerance, since it is one of the excipients contained in both the drug and placebo. ·Contraindication of flunarizine according to study data sheet (eg, extrapyramidal symptoms, depressive syndrome), or according to the physician discretion. ·Patients taking hypnotics or sedatives, or who consume alcohol on a regular basis, as flunarizine may enhance their sedative effect. ·Patients treated with the following medication that cannot be suspended during the conduct of the trial (for having an indication other than migraine): calcium antagonists, beta-blockers, tricyclic antidepressants, and inhibitors of serotonin re-uptake, some antiepileptics (topiramate, zonisamide, valproic acid), or antiserotoninergic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of flunarizine versus placebo in preventing migraine in a pediatric population from 7 to 14 years, measured as the reduction in monthly frequency of attacks.;Secondary Objective: - To evaluate the secondary efficacy of flunarizine versus placebo in the prevention of migraine in the pediatric population from 7 to 14 years, measured as the reduction of the duration of migraine attacks. - To evaluate the secondary efficacy of flunarizine versus placebo in the prevention of migraine in the pediatric population from 7 to 14 years, measured as reduction in the intensity of migraines. - Analyze the safety of flunarizine by monitoring and detection of adverse events occurring during the study period. - Analyze the quality of life related to health (HRQOL) of these patients before and after preventive treatment, using the questionnaire PEDM.;Primary end point(s): - Number of migraine attacks every 4 weeks. The number of migraine attacks should be considered independently of its duration. An episode of migraine that remits temporarily but recurs within 72 hours after the start of the first episode should be considered as a single episode.;Timepoint(s) of evaluation of this end point: Every 4 weeks from the first visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Response Rate. 50% improvement. It is defined as "respondent" a patient with 50% or more reduction in seizure frequency during treatment compared to the number of attacks at baseline. - Number of days with migraine every 4 weeks. - Intensity of Migraine: We will use the following scale: 1 = mild migraine, does not interfere with activities of daily living. 2 = moderate migraine, disturbed but does not completely interfere in the activities of daily living. 3 = severe migraine, precludes any activity, allowing only lying down or sleeping. - Duration in hours. It will be recorded for each migraine attack. - Symptomatic treatment for acute attacks: 4 pain relievers groups allowed, describing the dose used, start date and end. - Quality of life related to health (HRQOL): PEDM questionnaire at the screening visit and at the end of the treatment. - Adherence to treatment: by counting the number of returned capsules medication. Safety Variables - Appearance of any serious adverse events. - Weight gain of 7% or greater at study end.;Timepoint(s) of evaluation of this end point: Number of days with migraine, intensity, duration, and symptomatic treatment, will be evaluated every 4 weeks from visit 1 to visit 5. Quality of life related to health: in visits 1 and 5. Adherence to treatment: visits 3, 4 and 5. Occurrence of serious adverse events: from visit 1 to visit 6. Weight gain: at visit 1 and visit 6. | — |
Countries
Spain
Contacts
Public ContactUCICEC CAIBER Albacete
CAIBER
Outcome results
None listed