8993
document
Rizatriptan 5 mg for the acute treatment of migraine in adolescents : a randomized , double-blind , placebo-controlled study . OBJECTIVE To investigate the tolerability and efficacy of rizatriptan 5 mg in adolescent migraineurs . METHODS Randomized , double-blind , placebo-controlled study . Patients aged 12 to 17 years received rizatriptan 5 mg ( n = 149 ) or placebo ( n = 147 ) for a moderate or severe headache and for up to two recurrences . Headache severity , presence or absence of associated symptoms , and functional disability were assessed over a 4-hour postdose period , and any adverse events were recorded . The primary efficacy measure was pain-free status at 2 hours postdose . RESULTS Rizatriptan 5 mg was well tolerated . The most commonly reported adverse events ( all with incidence of 5 % or less ) among patients receiving rizatriptan were dry mouth , dizziness , asthenia/fatigue , nausea , and somnolence . The percentage of patients pain-free at 2 hours was 32 % for rizatriptan 5 mg versus 28 % for placebo ( P=.474 ) . The percentage of patients with pain relief ( reduction of predose pain intensity to mild or none ) at 2 hours was 66 % for rizatriptan versus 56 % for placebo ( P=.079 ) . Placebo response rates were higher than those typically observed in previous studies of rizatriptan in adults . Compared with placebo , rizatriptan significantly improved functional disability at 1.5 and 2 hours , and nausea at 1 and 1.5 hours . Post hoc analysis showed a significant benefit of rizatriptan versus placebo in the percentage of patients who had pain relief when their migraine attacks were treated on weekends ( 65 % versus 36 % , P=.046 ) compared with weekdays ( 66 % versus 61 % , P=.365 ) , and the weekend placebo response rate was similar to that seen in adults . CONCLUSIONS Rizatriptan 5 mg was well tolerated and effective on some measures when used in adolescents for the treatment of a migraine attack .
8994
Intervention_Pharmacological
Rizatriptan
8995
Intervention_Control
placebo-controlled
8996
Intervention_Pharmacological
rizatriptan
8997
Intervention_Pharmacological
rizatriptan
8998
Intervention_Control
placebo
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Intervention_Pharmacological
Rizatriptan
9000
Intervention_Pharmacological
rizatriptan
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Intervention_Pharmacological
rizatriptan
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Intervention_Control
placebo
9003
Intervention_Control
Placebo
9004
Intervention_Pharmacological
rizatriptan
9005
Intervention_Control
placebo
9006
Intervention_Pharmacological
rizatriptan
9007
Outcome_Other
tolerability and efficacy
9008
Outcome_Physical
Headache severity
9009
Outcome_Physical
presence or absence of associated symptoms
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Outcome_Physical
functional disability
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Outcome_Adverse-effects
adverse events
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Outcome_Pain
pain-free status at 2 hours postdose
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Outcome_Adverse-effects
adverse events
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Outcome_Adverse-effects
dry mouth , dizziness , asthenia/fatigue , nausea , and somnolence
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Outcome_Pain
pain-free
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Outcome_Pain
percentage of patients with pain relief
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Outcome_Pain
predose pain intensity
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Outcome_Physical
Placebo response rates
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Outcome_Physical
functional disability
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Outcome_Adverse-effects
nausea
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Outcome_Pain
pain relief
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Outcome_Physical
response rate
9023
Outcome_Other
tolerated and effective
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Participant_Condition
migraine
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Participant_Age
adolescents
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Participant_Age
12 to 17 years
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Participant_Sample-size
149
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Participant_Sample-size
147
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Participant_Condition
attack