‘Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache’ have been published in Cephalalgia.

The first edition of the guidelines were published in 1995 and have not been revised until now. With the emergence of new medications, neuromodulation devices and trial designs, an updated version was warranted.

Given the scarcity of evidence-based data for cluster headache therapies, the update is largely consensus-based, but takes into account lessons learned from recent trials and demands by patients. It is intended to apply to both drug and neuromodulation treatments, with specific proposals for the latter when needed.

The primary objective is to propose a template for designing high quality, state-of-the-art, controlled clinical trials of acute and preventive treatments in episodic and chronic cluster headache. The recommendations should not be regarded as dogma and alternative solutions to particular methodological problems should be explored in the future and scientifically validated.

Read the guidelines in Cephalalgia.