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Pizotifen (Sanomigran) in childhood migraine. A double-blind controlled trial
Insights
Pizotifen did not significantly reduce migraine attacks in children compared to placebo. The drug was well-tolerated, but showed no clinical benefit in this double-blind crossover trial.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Migraine is a common neurological disorder in children.
- Pizotifen is a medication sometimes used for migraine prophylaxis.
Purpose of the Study:
- To evaluate the efficacy of pizotifen in reducing migraine frequency and severity in children.
- To assess the tolerability of pizotifen in a pediatric population.
Main Methods:
- A double-blind, placebo-controlled, cross-over study design was employed.
- Forty-seven children diagnosed with migraine participated.
- Participants received either pizotifen or placebo for three months, followed by the alternative treatment.
Main Results:
- Thirty-nine children completed the study.
- No statistically significant difference was observed in the reduction of attack number, total duration, mean duration, or longest attack duration between pizotifen and placebo groups.
- Pizotifen was found to be well-tolerated by the pediatric participants.
Conclusions:
- Pizotifen did not demonstrate significant efficacy in treating pediatric migraine in this study.
- Further research may be needed to explore alternative prophylactic treatments for childhood migraine.
Abstract:
Forty-seven children with migraine have been included in a double-blind cross-over study with pizotifen and placebo. The children received either pizotifen for 3 months followed by placebo or vice versa. Thirty-nine children completed the trial and there was no significant difference between active and placebo treatment as regards reduction of number of attacks, total and mean duration of attacks and duration of longest attacks. Pizotifen was well tolerated by the children.