OBJECTIVE: To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents. METHODS: A double-blind, placebo-controlled, two-way crossover trial was conducted in three hospital outpatient departments, with 8 to 17 year olds diagnosed with migraine serving as subjects (International Headache Society 1988). A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks. The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of >/==" BORDER="0">40 kg. The primary efficacy endpoint was headache relief by two grades on a 5-grade face scale at 2 hours. RESULTS: Eighty-three patients used both treatments and 11 only the first. At 2 hours, the primary endpoint was reached nearly twice as often after sumatriptan (n = 53/83; 64%) as after placebo (n = 32/83; 39%) (p = 0.003). Already at 1 hour, headache relief was seen more often after sumatriptan (n = 42/83; 51%) than after placebo (n = 24/83; 29%) (p = 0.014). The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses (n = 94). Other endpoints, including child's preference and using rescue medication, also favored sumatriptan. The most common adverse effect was a bad taste after sumatriptan, reported in 29% (n = 26/90) of the attacks. No serious adverse effects were observed. CONCLUSION:Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age.
RCT Entities:
OBJECTIVE: To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents. METHODS: A double-blind, placebo-controlled, two-way crossover trial was conducted in three hospital outpatient departments, with 8 to 17 year olds diagnosed with migraine serving as subjects (International Headache Society 1988). A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks. The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of >/==" BORDER="0">40 kg. The primary efficacy endpoint was headache relief by two grades on a 5-grade face scale at 2 hours. RESULTS: Eighty-three patients used both treatments and 11 only the first. At 2 hours, the primary endpoint was reached nearly twice as often after sumatriptan (n = 53/83; 64%) as after placebo (n = 32/83; 39%) (p = 0.003). Already at 1 hour, headache relief was seen more often after sumatriptan (n = 42/83; 51%) than after placebo (n = 24/83; 29%) (p = 0.014). The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses (n = 94). Other endpoints, including child's preference and using rescue medication, also favored sumatriptan. The most common adverse effect was a bad taste after sumatriptan, reported in 29% (n = 26/90) of the attacks. No serious adverse effects were observed. CONCLUSION: Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age.
Authors: Johanna Lindkvist; Marja Airaksinen; Ann Marie Kaukonen; Timo Klaukka; Kalle Hoppu Journal: Br J Clin Pharmacol Date: 2011-06 Impact factor: 4.335