Prophylactic effects of psilocybin on chronic cluster headache: an open-label clinical trial and neuroimaging study.

Phase 1

• Conditions: Chronic cluster headache.; MedDRA version: 21.1 Level: LLT Classification code 10056941 Term: MRI brain System Organ Class: 100000004848; MedDRA version: 21.1 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 100000004852; MedDRA version: 21.1 Level: LLT Classification code 10020397 Term: Horton's headache System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003382-34-DK
• Lead Sponsor: euroPharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-30
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).
•Current use of drugs suspected 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified