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TerminatedPhase 1 / Phase 2

Prophylactic Effects of Psilocybin on Chronic Cluster Headache

NCT04280055 · EPOCH · Gitte Moos Knudsen

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
10
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The purpose of this study is to investigate the prophylactic effects of psilocybin in chronic cluster headache. Subjects will receive a low dose of psilocybin during 3 sessions spaced by one week. Subjects will maintain a headache diary prior to, during, and after the administrations in order to document headache frequency, intensity and duration. Subjects will undergo a fMRI scanning before the first and after the last psilocybin session.

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

  • Headache frequency

    Measured over Week 6-10 (post drug observation) compared to week 0-4 (baseline observation)

  • Resting state FC fMRI analyses

    Measured over Day 1 of first psilocybin session to 1 week after last psilocybin session (3 weeks)

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

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age between 18 and 65 * A diagnosis of chronic cluster headache according to IHCD-III. * Ability to separate cluster headache attacks from other types of headache. * A history of at least 4 attacks/week in the last 4 weeks before inclusion Exclusion Criteria: * A history of using a serotonergic hallucinogen for CH. * Participation in any clinical trials within 30 days preceding study enrollment. * Use of other prophylactic CH medication within the last two weeks. * Current use of drugs suspected to interfere with treatment (e.g. antipsychotic medication) or to be hazardous in combination with psilocybin. * Presence of other trigeminal autonomic cephalalgias. * Known hypersensitivity/allergy to multiple drugs (including psilocybin). * A history or presence of any medical and psychiatric condition that might render patient unsuitable for participation. * Present or previous manic or psychotic disorder or critical psychiatric disorder. * Current drug or alcohol abuse. * MRI Contraindications. * Pregnancy or breastfeeding * Not using safe contraception (if fertile woman) * Stroke (\<1 year from inclusion) * Myocardial infarction (\<1 year from inclusion) * Hypertension (\> 140/90 mmHg at inclusion) * Clinically significant arrhythmia (\<1 year from inclusion)

Where

1 study site

FacilityCityRegionCountry
Neurobiology Research Unit, RigshospitaletCopenhagenDenmark

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.

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NCT04280055 on ClinicalTrials.gov →

Last updated in the registry 2022-08-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits