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document
Safety and efficacy of PNU-142633 , a selective 5-HT1D agonist , in patients with acute migraine . In this randomized , double-blind , placebo-controlled , parallel-group study , patients received a single 50-mg oral dose of a 5-HT ( 1D ) agonist , PNU-142633 ( n = 34 ) , or matching placebo ( n = 35 ) during an acute migraine attack . No statistically significant treatment effects were observed at 1 and 2 h after dosing , even after stratifying by baseline headache intensity . At 1 and 2 h post-dose , 8.8 % and 29.4 % of the PNU-142633 group , respectively , and 8.6 % and 40.0 % of the placebo group , respectively , experienced headache relief ; 2.9 % and 8.8 % of the PNU-142633 group and 0 % and 5.7 % of the placebo group were free of headache pain . Adverse events associated with PNU-142633 treatment included chest pain ( two patients ) and QTc prolongation ( three patients ) . Results from this study suggest that anti-migraine efficacy is not mediated solely through the 5-HT ( 1D ) receptor subtype , although this receptor may contribute , at least in part , to the adverse cardiovascular effects observed with 5-HT agonist medications .
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Intervention_Pharmacological
PNU-142633 , a selective 5-HT1D agonist
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Intervention_Control
matching placebo
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Intervention_Pharmacological
PNU-142633
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Intervention_Pharmacological
5-HT agonist
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Outcome_Physical
headache relief
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Outcome_Pain
free of headache pain .
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Outcome_Adverse-effects
Adverse events
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Outcome_Adverse-effects
chest pain
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Outcome_Physical
QTc prolongation
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Participant_Condition
acute migraine
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Participant_Condition
acute migraine