Objective. -To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects. Background. -Currently, no triptan is approved ...Objective. -To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects. Background. -Currently, no triptan is approved in the United States for the treatment of migraine in adolescent subjects (12 to 17 years). In a previous randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance (P= .059). A second study was initiated to evaluate the efficacy of sumatriptan NS in this population. Methods. -This was a randomized (1:1:1), placebo-controlled, doubleblind, parallel-group study. Overall, 738 adolescent subjects (mean age: 14 years) with ≥6-month history of migraine (with or without aura) self-treated a single attack of moderate or severe migraine. The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours. Pain-free rates, presence/absence of associated symptoms, headache recurrence, and use of rescue medications were also assessed. Tolerability was based on adverse events (AEs) and vital signs. Results. -Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes (42%vs. 33%, respectively; P= .046) and 2 hours (68%vs. 58%; P= .025) postdose, but did not reach statistical significance at 1 hour (61%vs. 52%; P= .087) or for sustained headache relief from 1 to 24 hours (P= .061). Significant differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours. In general, sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance. Both doses of sumatriptan NS were well tolerated. No AEs were serious or led to study withdrawal. The most common event was taste disturbance (2%, placebo; 19%, sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). Conclusions. -This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population.展开更多
Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a rand...Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a randomized, double blind, placebo controlled, single attack study followed by a randomized, 1 ye ar, open label extension. The second study was a randomized, 1 year, open lab el study. In the single attack study, patients treated a moderate or severe mig raine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234 ) or placebo (n = 242). Patients were instructed to use the study medication onl y on nonschool days. Headache severity, associated symptoms, and functional disa bility were assessed by the patient at 0.5,1, 1.5, 2, 3, and 4 hours after the i nitial dose. In the 1 year studies, patients treated up to 6 migraine attacks p er month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. Results. In the single attack study, the proportion of patients with pain relief at 2 hours was not significan tly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer pat ients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significant ly higher in the rizatriptan group than in the placebo group (74%vs. 58%, P = 0.022). In the multiple attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not signif icantly different from that of placebo or standard care. Conclusions. Rizatrip tan 5 mg was not more effective than placebo in the treatment of a single migrai ne attack in adolescents, but appeared to be more effective than standard care f or treating multiple attacks occurring over 1 year in these patients. Rizatripta n 5 mg was well tolerated in adolescents during short term and long term use.展开更多
文摘Objective. -To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects. Background. -Currently, no triptan is approved in the United States for the treatment of migraine in adolescent subjects (12 to 17 years). In a previous randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance (P= .059). A second study was initiated to evaluate the efficacy of sumatriptan NS in this population. Methods. -This was a randomized (1:1:1), placebo-controlled, doubleblind, parallel-group study. Overall, 738 adolescent subjects (mean age: 14 years) with ≥6-month history of migraine (with or without aura) self-treated a single attack of moderate or severe migraine. The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours. Pain-free rates, presence/absence of associated symptoms, headache recurrence, and use of rescue medications were also assessed. Tolerability was based on adverse events (AEs) and vital signs. Results. -Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes (42%vs. 33%, respectively; P= .046) and 2 hours (68%vs. 58%; P= .025) postdose, but did not reach statistical significance at 1 hour (61%vs. 52%; P= .087) or for sustained headache relief from 1 to 24 hours (P= .061). Significant differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours. In general, sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance. Both doses of sumatriptan NS were well tolerated. No AEs were serious or led to study withdrawal. The most common event was taste disturbance (2%, placebo; 19%, sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). Conclusions. -This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population.
文摘Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a randomized, double blind, placebo controlled, single attack study followed by a randomized, 1 ye ar, open label extension. The second study was a randomized, 1 year, open lab el study. In the single attack study, patients treated a moderate or severe mig raine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234 ) or placebo (n = 242). Patients were instructed to use the study medication onl y on nonschool days. Headache severity, associated symptoms, and functional disa bility were assessed by the patient at 0.5,1, 1.5, 2, 3, and 4 hours after the i nitial dose. In the 1 year studies, patients treated up to 6 migraine attacks p er month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. Results. In the single attack study, the proportion of patients with pain relief at 2 hours was not significan tly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer pat ients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significant ly higher in the rizatriptan group than in the placebo group (74%vs. 58%, P = 0.022). In the multiple attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not signif icantly different from that of placebo or standard care. Conclusions. Rizatrip tan 5 mg was not more effective than placebo in the treatment of a single migrai ne attack in adolescents, but appeared to be more effective than standard care f or treating multiple attacks occurring over 1 year in these patients. Rizatripta n 5 mg was well tolerated in adolescents during short term and long term use.
