LSD to Improve Cluster Headache Impact Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
LSD tartrate: LSD tartrate equivalent to 25 microgram LSD base
Placebo: Placebo with equal appearance
Study summary
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.
Eligibility
Primary outcome measure(s)
- Mean change in weekly attack frequency, across treatments groups. — week 3 of treatment
In week 3 post-randomization, compared to the 4-week baseline average per week
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Leiden University Medical Center (LUMC) | Leiden | Netherlands | Recruiting |
| Canisius-Wilhelmina Ziekenhuis (CWZ) | Nijmegen | Netherlands | Recruiting |
More Radboud University Medical Center trials in the Netherlands
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05477459 on ClinicalTrials.gov ↗ ← All trials in the Netherlands