This double-blind, placebo-controlled trial (n=65) will assess the efficacy and safety of LSD (25μg) every 3 days for 3 weeks versus placebo in treating chronic cluster headaches (CCH).
Conducted by Radboud University Medical Center, the study aims to address the considerable unmet need for effective treatments for cCH. The primary objective is to evaluate the efficacy of LSD in reducing cluster headache frequency, with additional objectives including safety evaluation, exploration of exposure-response relationship, assessment of hypothalamic functional connectivity using rsMRI, exploration of cost-effectiveness, and evaluation of health-related quality of life.
Participants will be between 16 to 75 years old and must meet inclusion criteria such as stable weekly attack frequency. The study is set to begin in January 2024 and estimated to complete by August 2025. If positive, this study could lead to LSD being further studied for routine clinical use in treating cCH.
Trial Details
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Sponsors & Collaborators
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