Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

Summary

This is a clinical trial to assess the efficacy of botox treatment of the sphenopalatine ganglion as an add-on treatment in drug resistant migraine. An injection targeting the ganglion is made possible by an image-guided device developed specifically for this purpose (MultiGuide) Study participants will be randomized to either placebo or botox after a 4 week run-in period. First, one injection will be given towards both the right and the left ganglion. After that there will be a follow-up of 12 weeks for efficacy and safety evaluation. The main efficacy measure is change in number of moderate to severe headache days before and after injection.

Timeline

Start

2019-10-01

Primary completion

2025-06-13

Completion

2026-06

Publications

• Wergeland T, Simpson M, Aschehoug I, Oie L, Hara S, Skalstad ETV, Salvesen O, Tronvik E, Bratbak D. OnabotulinumtoxinA blockade of the sphenopalatine ganglion in treatment-resistant chronic migraine (MiBlock): rationale, design and study protocol for a multi-centre, investigator initiated, randomised, quadruple-blinded placebo-controlled trial. F1000Res. 2026 Feb 5;14:564. doi: 10.12688/f1000research.164241.2. eCollection 2025.

Drugs

Indications