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Prophylactic Effects of Psilocybin on Chronic Cluster Headache

NCT04280055 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-10

No results posted yet for this study

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.

Conditions

  • Cluster Headache

Interventions

DRUG

Psilocybin

0.14 mg/kg p.o. in three sessions spaced by one week

Sponsors & Collaborators

  • Gitte Moos Knudsen

    lead OTHER

Principal Investigators

  • Gitte Moos Knudsen, MD, DMSc · Neurobiology Research Unit, Rigshospitalet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2020-11-01
Completion
2022-06-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04280055 on ClinicalTrials.gov