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

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.

• Authors: B Gomez-Mancilla, 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
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 21 Issue 7 Pg. 727-32 (Sep 2001) ISSN: 0333-1024 [Print] England
• PMID: 11595000 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Chromans
• Receptor, Serotonin, 5-HT1D
• Receptors, Serotonin
• Serotonin Receptor Agonists
• PNU 142633F

Topics

• Acute Disease
• Adolescent
• Adult
• Chromans (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Receptor, Serotonin, 5-HT1D
• Receptors, Serotonin (physiology)
• Serotonin Receptor Agonists (adverse effects, therapeutic use)