Study for prevention with flunarizine of migraine attacks in childre

• Conditions: Prevention of migraine attacks in pediatric population.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-019947-21-ES
• Lead Sponsor: CAIBER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-03
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

·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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified