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Recruiting Phase 2

LSD to Improve Cluster Headache Impact Trial

NCT05477459 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2025-04-16
Last updated
2025-04-15

Condition(s) studied

Chronic Cluster Headache

Investigational drug(s) / intervention(s)

LSD tartratePlacebo

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

Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * CCH according to the International Classification of Headache Disorders version 3 (ICHD-3) * At screening: stable weekly attack frequency in the 4 weeks prior to screening (assessed retrospectively), averaging at least 8 per week and each week within a 40% window around the average * At randomization: average of at least 8 attacks per week and no absence of attacks on more than two consecutive days during baseline Exclusion Criteria: * Use of excluded concomitant treatment at screening (lithium; other prophylactics if not on a stable dose for less than one month; steroids/GON block within 2 months before screening; sphenopalatinum block, neurostimulation (changed setting within 3 months before screening) or botulinum toxin within 3 months before screening) and during the double-blind phase * Use of LSD(-derivatives) (other than investigational drug), psilocybin, ketamine or cannabis within 3 months prior to screening and throughout the study * Lifetime and/or family history (first degree relatives) of psychotic or bipolar disorder, suicidal intention or attempt * A score of 6 or more on the 'Ervaringenlijst' (PQ-16) to exclude subclinical susceptibility to psychosis * Actual abuse of alcohol and/or recreational drugs * Lifetime history of cardiac valvular disease * History or evidence of cognitive disorder at screening * Positive urine drug screen at screening * Females: Pregnancy, lactation, no acceptable contraceptive use

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)

FacilityCityRegionStatus
Leiden University Medical Center (LUMC) Leiden Netherlands Recruiting
Canisius-Wilhelmina Ziekenhuis (CWZ) Nijmegen Netherlands Recruiting
Official registry record

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