A phase 2 trial (NCT03781128) for lysergic acid diethylamide (LSD) pulse regimen (Mind Medicine, Basel, Switzerland) for cluster headache treatment started recruiting participants in early January 2020. The phase 2 trial is investigating the effects of an oral LSD pulse regimen of 3 microdoses (100 mcg) in a 3-week time period, in 30 participants with cluster headaches. The study is a double blind randomized placebo-controlled 2-phase cross-over study design.
Thus far, there is only 1 treatment approved by the Food and Drug Administration (FDA) for cluster headaches the need for novel treatments still remains. Anecdotal evidence suggests LSD can decrease the frequency and intensity of cluster headaches .
Mind Medicine cofounder and cochief executive officer, JR Rahn said "As we continue on our mission to discover, develop and deploy psychedelic inspired medicines, we are very encouraged to bring this potential treatment for cluster headaches using LSD out of the shadows and evaluate its efficacy based on clinical research standards with the Liechti Lab."
At a later date, there will be an assessment on whether there is clinical evidence for a future commercial drug trial through the FDA pathway. Treatments for cluster headaches may potentially qualify for an orphan drug designation and be eligible for certain development incentives provided by the FDA for rare diseases.
F. Stephen Benesh, MD, and Shruti P. Agnihotri, MD
Bettina Balint, MD
James Geyer, MD, and Paul Cox