[P3-183] Cinnarizine for the prophylaxis of Children and Adolescents Migraine Headache
BACKGROUND:
Migraine, as a common health problem has still no FDA approved preventive drug in patients under the age of 18 . Cinnarizine is an L-type calcium channel blocker that have been demonstrated to be effective in migraine prophylaxis . We planned 4 prospective studies for the evaluation of the efficacy and safety of cinnarizine in comparison to Propranolol , Sodium valproate, Topiramate and placebo among children and adolescents.
Materials & Methods
Children (5-17 years) with migraine, that referred to Children’s Medical Center in Tehran, Iran, were recruited into these double-blind studies. Each participant was randomly assigned to receive Cinnarizine or other agents . The frequency, severity, and duration of headaches over the trial period were assessed and adverse effects were monitored. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate.
RESULTS: In the first study 74.6% of Cinnarizine and 72.5% of Propranolol group were responders without significant difference (P = 0.358). In the second study 75% of Cinnarizine and 74% of Sodium valproate group were responders without significant difference . In the third study, 85% of the Cinnarizine group and 65% of the Topiramate group were responders without significant difference. At the final study 60% of children in the Cinnarizine group compared with 31.3% of children in the placebo group were responders with significant difference (P = 0.023) .
CONCLUSION: Our results indicate that Cinnarizine is effective and safe for prophylaxis of migraine in children.
Key Words :: Children, Migraine, Cinnarizine, Sodium valproate , Propranolol, Topiramate, Placebo
Migraine, as a common health problem has still no FDA approved preventive drug in patients under the age of 18 . Cinnarizine is an L-type calcium channel blocker that have been demonstrated to be effective in migraine prophylaxis . We planned 4 prospective studies for the evaluation of the efficacy and safety of cinnarizine in comparison to Propranolol , Sodium valproate, Topiramate and placebo among children and adolescents.
Materials & Methods
Children (5-17 years) with migraine, that referred to Children’s Medical Center in Tehran, Iran, were recruited into these double-blind studies. Each participant was randomly assigned to receive Cinnarizine or other agents . The frequency, severity, and duration of headaches over the trial period were assessed and adverse effects were monitored. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate.
RESULTS: In the first study 74.6% of Cinnarizine and 72.5% of Propranolol group were responders without significant difference (P = 0.358). In the second study 75% of Cinnarizine and 74% of Sodium valproate group were responders without significant difference . In the third study, 85% of the Cinnarizine group and 65% of the Topiramate group were responders without significant difference. At the final study 60% of children in the Cinnarizine group compared with 31.3% of children in the placebo group were responders with significant difference (P = 0.023) .
CONCLUSION: Our results indicate that Cinnarizine is effective and safe for prophylaxis of migraine in children.
Key Words :: Children, Migraine, Cinnarizine, Sodium valproate , Propranolol, Topiramate, Placebo