LSD to Improve Cluster Headache Impact Trial

This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH). It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period. Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH. Additional objectives: * To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. * To explore the exposure-response relationship of 25μg LSD in cCH. * To explore cost-effectiveness of treatment with LSD in cCH. * To evaluate the efficacy of LSD on health-related quality of life.

NCT Number	NCT05477459
Lead Sponsor	Radboud University Medical Center Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Canisius-Wilhelmina Hospital, Leiden University Medical Center
Conditions	Chronic Cluster Headache
Enrollment	65 participants
Start Date	2025-04-16
Primary Completion	2027-04 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2025-04-15