Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study.

Abstract

BACKGROUND:

A novel formulation of diclofenac, complexed with hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer, in a prefilled syringe for self-administered subcutaneous injection may overcome the limitations of acute migraine treatments administered by oral, rectal, intramuscular, or intravenous routes.

METHODS:

This multicentre, phase 2, double-blind, randomized, placebo-controlled, dose-finding pilot study evaluated the efficacy, safety and tolerability of three different doses (25/50/75 mg/1 mL) of subcutaneous diclofenac sodium in the treatment of an acute migraine attack in 122 subjects. The primary efficacy endpoint was the percentage of patients pain-free at 2 hours after the study drug injection.

RESULTS:

A significantly higher percentage of patients in the 50 mg diclofenac group 14 (46.7%) were pain-free at 2 hours when compared with placebo: 9 (29.0%) (p = 0.01). The 50 mg dose proved superior to placebo also in the majority of the secondary endpoints. The overall global impression favoured diclofenac vs placebo. There were no adverse events leading to study withdrawal. The majority of treatment-emergent adverse events were mild.

CONCLUSIONS:

The 50 mg dose of this novel formulation of diclofenac represents a valuable self-administered option for the acute treatment of migraine attacks.Trial registration: EudraCT Registration No. 2017-004828-29.

• Authors: Pierangelo Geppetti, Francesco De Cesaris, Silvia Benemei, Pietro Cortelli, Sabina Cevoli, Giulia Pierangeli, Valentina Favoni, Carlo Lisotto, Susanna Usai, Fabio Frediani, Paola Di Fiore, Giacomo D'Arrigo, Cristina Tassorelli, Grazia Sances, Maria Michela Cainazzo, Carlo Baraldi, Paola Sarchielli, Ilenia Corbelli, Gioacchino De Vanna, Gioacchino Tedeschi, Antonio Russo, Italian 17I-DCsc09 Study Team
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 42 Issue 10 Pg. 1058-1070 (09 2022) ISSN: 1468-2982 [Electronic] England
• PMID: 35469478 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Diclofenac

Topics

• Diclofenac (adverse effects)
• Double-Blind Method
• Humans
• Infusions, Intravenous
• Migraine Disorders (chemically induced, drug therapy)
• Pilot Projects