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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003382-34-DK

Enrollment

Registered

2018-08-30

Start date

2019-06-17

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Cl

Interventions

Product Name: Psilocybin Pharmaceutical Form: Capsule INN or Proposed INN: PSILOCYBINE CAS Number: 520-52-5 Concentration unit: mg/kg mi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 ( 140/90 mmHg at inclusion). • Clinically significant arrhythmia (<1 year from inclusion).

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the present open-label trial is to evaluate the effect of psilocybin on chronic cluster headache (i.e., headache frequency). ;Secondary Objective: Additional objectives are to 1) evaluate changes in brain function and correlations with potential clinical effects, 2) evaluate the extent to which plasma psilocin levels correlate with clinical effects. ; Timepoint(s) of evaluation of this end point: 1.In week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 2.At baseline and at MRI rescan. ; Primary end point(s): 1.Change in headache frequency in number of attacks/week. 2.Resting state FC fMRI analyses, including hypothalamic FC, comparing baseline and rescan, comparison with healthy control sample, and evaluation of correlation between headache frequency changes and FC changes	—

Measure

Time frame

Main Objective: The main objective of the present open-label trial is to evaluate the effect of psilocybin on chronic cluster headache (i.e., headache frequency). ;Secondary Objective: Additional objectives are to 1) evaluate changes in brain function and correlations with potential clinical effects, 2) evaluate the extent to which plasma psilocin levels correlate with clinical effects. ; Timepoint(s) of evaluation of this end point: 1.In week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 2.At baseline and at MRI rescan. ; Primary end point(s): 1.Change in headache frequency in number of attacks/week. 2.Resting state FC fMRI analyses, including hypothalamic FC, comparing baseline and rescan, comparison with healthy control sample, and evaluation of correlation between headache frequency changes and FC changes

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Secondary

Measure	Time frame
Secondary end point(s): 1.Proportion of patients with a 50% reduction in headache frequency in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 2.Change in average headache intensity in number of attacks/week in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 3.Number of attacks requiring acute therapy in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 4.Proportion of patients experiencing serious side effects. 5.Proportion of patients with remission lasting more than 1 month. 6.Duration of induced remission (number of weeks) 7.Proportion of patients who changes from CCH to eCH. 8.Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36) in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline 9.Proportion of patients that prefers to continue with psilocybin if this was an option or want to return to usual prophylactics 10.Changes in mood (POMS), perceived stress (PSS), sleep quality (PSQI) and depressive symptoms (MDI) pre-psilocybin (week 1 and 5) vs post-psilocybin (week six and eight). ; Timepoint(s) of evaluation of this end point: 1-3,8. week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 4. All study. 5-7,9. All study. Data collection at 3, 6 and 12 months. 10. Pre psilocybin Week 1 and 5 vs post-psilocybin Week six and eight.	—

Measure

Time frame

Secondary end point(s): 1.Proportion of patients with a 50% reduction in headache frequency in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 2.Change in average headache intensity in number of attacks/week in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 3.Number of attacks requiring acute therapy in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 4.Proportion of patients experiencing serious side effects. 5.Proportion of patients with remission lasting more than 1 month. 6.Duration of induced remission (number of weeks) 7.Proportion of patients who changes from CCH to eCH. 8.Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36) in week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline 9.Proportion of patients that prefers to continue with psilocybin if this was an option or want to return to usual prophylactics 10.Changes in mood (POMS), perceived stress (PSS), sleep quality (PSQI) and depressive symptoms (MDI) pre-psilocybin (week 1 and 5) vs post-psilocybin (week six and eight). ; Timepoint(s) of evaluation of this end point: 1-3,8. week 6-10, i.e. the four weeks after the last psilocybin dose, compared to the four-week baseline. 4. All study. 5-7,9. All study. Data collection at 3, 6 and 12 months. 10. Pre psilocybin Week 1 and 5 vs post-psilocybin Week six and eight.

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Countries

Denmark

Contacts

Public ContactNeuroPharm

NeuroPharm

gmk@nru.dk4535456720

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026