Safety and efficacy of PNU-142633, a selective 5-HT1D agonist, in patients with acute migraine

  • Cephalalgia. 2001 Sep;21(7):727-32. doi: 10.1046/j.1468-2982.2001.00208.x.
B Gomez-Mancilla  1 ,  N R Cutler ,  M T Leibowitz ,  E L Spierings ,  J A Klapper ,  S Diamond ,  J Goldstein ,  T Smith ,  J R Couch ,  J Fleishaker ,  N Azie ,  D E Blunt
Affiliations
PMID: 11595000 DOI: 10.1046/j.1468-2982.2001.00208.x
Abstract

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.

Products