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RecruitingPhase 2

LSD to Improve Cluster Headache Impact Trial

NCT05477459 · LICIT · Radboud University Medical Center

Recruiting
Status
Accepting participants
Phase 2
Phase
65
Target enrolment
2
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Mean change in weekly attack frequency, across treatments groups.

    Measured over week 3 of treatment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

16 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

2 study sites

FacilityCityRegionCountry
Leiden University Medical Center (LUMC)LeidenNetherlands
Canisius-Wilhelmina Ziekenhuis (CWZ)NijmegenNetherlands

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05477459 on ClinicalTrials.gov →

Last updated in the registry 2025-04-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance