Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache
Status:
Not yet recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
Randomized double-blind placebo-controlled trial of LSD 25μg every 3 days for 3 weeks versus
placebo, followed by a 5-week post-treatment observation of persistence of efficacy, in
chronic cluster headache (CCH).
Main research objective
1. To assess the efficacy and utility of a 3-week course of LSD 25μg for the relief of CCH
Additional research objectives
2. To explore the persistence of effect at 8 weeks post-randomization
3. To assess the safety and tolerability of a 3-weeks treatment regimen
4. To assess the cost-effectiveness
5. To model the correlation of pharmacokinetic variables and pharmacodynamics effects
Phase:
Phase 2
Details
Lead Sponsor:
Canisius-Wilhelmina Hospital
Collaborators:
Leiden University Medical Center Radboud University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development