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Published on: June 2, 2014
Flunarizine in prophylaxis of childhood migraine. A double-blind, placebo-controlled, crossover study
F Sorge1, R De Simone, E Marano
1Department of Neurology, IInd School of Medicine, Naples, Italy.
Insights
Flunarizine effectively reduces migraine frequency and duration in children. This study found flunarizine to be a safe and effective prophylactic treatment for childhood migraine.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Migraine is a common neurological disorder in children.
- Prophylactic treatments are essential for managing frequent migraine attacks in pediatric populations.
Purpose of the Study:
- To evaluate the efficacy and safety of flunarizine for migraine prophylaxis in children.
- To assess the impact of flunarizine on migraine frequency, duration, and side effects.
Main Methods:
- An 8-month, double-blind, placebo-controlled, crossover trial involving 70 children.
- Participants received flunarizine (5 mg/day) or placebo for 12 weeks, followed by a 4-week washout and then crossed treatments.
Main Results:
- Flunarizine significantly reduced headache attack frequency and average duration in both treatment groups.
- Efficacy was maintained throughout the study period.
- Common side effects included daytime sedation and weight gain; no serious adverse events were reported.
Conclusions:
- Flunarizine is an effective prophylactic medication for childhood migraine.
- The drug demonstrates a favorable safety profile for pediatric use in short-term treatment.
Abstract:
An 8-month, double-blind, placebo-controlled, crossover trial of flunarizine in the prophylaxis of migraine has been performed in 70 children. After 4 weeks of medication-free base-line observation, 35 children (group A) received flunarizine (5 mg/day) and 35 (group B) received placebo over a 12-week period. After a 4-week washout they crossed treatments for another 12 weeks. Sixty-three patients completed the trial. In both groups flunarizine significantly reduced the frequency and average duration of headache attacks. In group A efficacy was maintained after placebo crossover for the last 4 months of the study. Five subjects in group B stopped placebo because of ineffectiveness; two children in group A discontinued flunarizine treatment, one because of excessive daytime sedation and the other because therapy was ineffective. The main side effects were daytime sedation and weight gain. It is concluded that flunarizine is an effective drug for the treatment of childhood migraine. In a study of this length no serious side effects were discovered.
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