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

Psilocybin

Brief 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)

Intervention / Treatment

An exploratory open-label phase 1b, ascending dose study
  • Psilocybin (DRUG)
    Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses

Condition or Disease

  • Short Lasting Unilateral Neuralgiform Headache Attacks

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 4 (ACTUAL)
    Funded by: Industry
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Aug 11, 2021 ACTUAL
    Primary Completion: Apr 22, 2022 ACTUAL
    Completion Date: Apr 22, 2022 ACTUAL
    Study First Posted: May 27, 2021 ACTUAL
    Last Updated: Oct 10, 2022

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    London, England, United Kingdom

    The study aims to:

    Determine the safety and tolerability of psilocybin when administered to patients with chronic SUNHA

    Determine the effects of psilocybin on cognition when administered to patients with chronic SUNHA

    Explore the change in frequency, duration, and intensity of headache attacks with escalating doses of psilocybin in patients with chronic SUNHA

    Participant Groups

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    \* Diagnosed with chronic SUNHA

    Exclusion Criteria:

    \* Other comorbidities

    Primary Outcomes
    • Percentage of patients with treatment emergent AEs (TEAES) 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 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 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 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 From first dose administered until the las dose administered, approximately 11 days
    • Change in frequency of headache attacks From screening until the follow up visit, approximately 39 days
    • Change in duration of headache attacks From screening until the follow up visit, approximately 39 days

    • Patients will complete a diary on a daily basis and capture the intensity of their headaches by assigning a score out of 10 where 0 is pain free and 10 is excruciating pain

    More Details

    NCT Number: NCT04905121
    Other IDs: BPL-PSILO-101
    Study URL: https://clinicaltrials.gov/study/NCT04905121
    Last updated: Sep 29, 2023