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TerminatedPhase 1

Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

NCT04905121 · Beckley Psytech Limited

Closed to entry
Status
Not accepting participants
Phase 1
Phase
4
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

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

  • Percentage of patients with treatment emergent AEs (TEAES)

    Measured over From first dose administered through to the last follow up visit, approximately 39 days

  • Treatment-related changes in Paired Associates Learning (PAL) scores and evaluation of dose response

    Measured over From first dose administered until the las dose administered, approximately 11 days

  • Treatment-related changes in Spatial Working Memory (SWM) scores and evaluation of dose response

    Measured over From first dose administered until the las dose administered, approximately 11 days

  • Treatment-related changes in Reaction Time Index (RTI) scores and evaluation of dose response

    Measured over From first dose administered until the las dose administered, approximately 11 days

  • Treatment-related changes in Rapid Visual Information Processing (RVP) scores and evaluation of dose response

    Measured over From first dose administered until the las dose administered, approximately 11 days

  • Change in frequency of headache attacks

    Measured over From screening until the follow up visit, approximately 39 days

  • Change in duration of headache attacks

    Measured over From screening until the follow up visit, approximately 39 days

  • Change in intensity of headache attacks

    Measured over From screening until the follow up visit, approximately 39 days

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 80 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: \* Diagnosed with chronic SUNHA Exclusion Criteria: \* Other comorbidities

Where

1 study site

FacilityCityRegionCountry
King's College LondonLondonUnited Kingdom

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.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04905121 on ClinicalTrials.gov →

Last updated in the registry 2022-10-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits