NCT04280055 (EPOCH) is a Phase 1, PHASE2 clinical trial of Psilocybin in Cluster Headache, sponsored by Gitte Moos Knudsen.

Who is sponsoring NCT04280055?

NCT04280055 is sponsored by Gitte Moos Knudsen.

What drugs are being tested in NCT04280055?

Interventions in NCT04280055: Psilocybin.

What condition does NCT04280055 study?

NCT04280055 studies Cluster Headache.

Is NCT04280055 still recruiting?

NCT04280055 is currently terminated. Last updated 10 August 2022.

Last reviewed 2022-08-10 · How we verify

NCT04280055: EPOCH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prophylactic Effects of Psilocybin on Chronic Cluster Headache

Terminated Phase 1, PHASE2 Last updated 10 August 2022

What this trial tests

Phase 1, PHASE2 trial testing Psilocybin in Cluster Headache in 10 participants. Terminated before completion.

Timeline

21 January 2020

Primary endpoint
1 November 2020

1 June 2022

Quick facts

Lead sponsor	Gitte Moos Knudsen
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	21 January 2020
Primary completion	1 November 2020
Estimated completion	1 June 2022
Sites	1 location across Denmark

Drugs / interventions tested

Psilocybin — full drug profile →

Conditions studied

Cluster Headache — all drugs for Cluster Headache →

Sponsor

Gitte Moos Knudsen — full company profile →

Who can join

Adults 18 to 65, any sex, with Cluster Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research.
Jacobs E, Murphy-Beiner A, Rouiller I, Nutt D, et al · · 2024 · cited 11× · PMID 37942467 · DOI 10.1007/s12152-023-09536-z
Classic Psychedelics in Pain Modulation: Mechanisms, Clinical Evidence, and Future Perspectives.
Czopek A, Jończyk J, Fryc M, Kluzik D, et al · · 2025 · cited 3× · PMID 40474592 · DOI 10.1021/acschemneuro.5c00152
Effects of psilocybin on sleep quality and brain microstructure in chronic cluster headache.
Brendstrup-Brix K, Ozenne B, Fisher PM, Stenbæk DS, et al · · 2026 · PMID 42212900 · DOI 10.1177/02698811261449380
Psilocybin-induced reduction in chronic cluster headache attack frequency correlates with changes in hypothalamic functional connectivity
Madsen MK, Petersen AS, Stenbæk DS, Sørensen IM, et al · · 2022 · DOI 10.1101/2022.07.10.22277414

Verify or expand the search:

Other trials of Psilocybin

Trials testing the same drug.

NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting
NCT07226232 — Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression · Phase 3 · not yet recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT07506395 — Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder · Phase 1 · not yet recruiting

Other recruiting trials for Cluster Headache

Currently open trials in the same condition.

NCT06540651 — Efficacy of Light Therapy in Treatment of Chronic Cluster Headache · NA · recruiting
NCT06277063 — nVNS for the Prevention and Treatment of Primary Headache · NA · recruiting
NCT06503328 — Role of Specific microRNAs in Cluster Headache · recruiting
NCT04406259 — Atrioventricular Block and Cluster Headache (SEVA) · Phase 4 · active not recruiting
NCT04939922 — China Headache and Vertigo Registry Study · recruiting

Other Gitte Moos Knudsen trials

Trials by the same sponsor.

NCT05450822 — Precision Medicine in the Treatment of Epilepsy · recruiting
NCT03576664 — Effects of Sleep Deprivation and Adrenergic Inhibition on Glymphatic Flow in Humans · EARLY_PHASE1 · completed
NCT03289949 — The Neurobiological Effect of 5-HT2AR Modulation · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04280055 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gitte Moos Knudsen
Last refreshed: 10 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04280055.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing