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

October 10, 2022 updated by: Beckley Psytech Limited

An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

* Diagnosed with chronic SUNHA

Exclusion Criteria:

* Other comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Psilocybin
Drug: Psilocybin
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with treatment emergent AEs (TEAES)
Time Frame: From first dose administered through to the last follow up visit, approximately 39 days
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
Time Frame: From first dose administered until the las dose administered, approximately 11 days
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
Time Frame: From first dose administered until the las dose administered, approximately 11 days
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
Time Frame: From first dose administered until the las dose administered, approximately 11 days
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
Time Frame: From first dose administered until the las dose administered, approximately 11 days
From first dose administered until the las dose administered, approximately 11 days
Change in frequency of headache attacks
Time Frame: From screening until the follow up visit, approximately 39 days
From screening until the follow up visit, approximately 39 days
Change in duration of headache attacks
Time Frame: From screening until the follow up visit, approximately 39 days
From screening until the follow up visit, approximately 39 days
Change in intensity of headache attacks
Time Frame: 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
From screening until the follow up visit, approximately 39 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckley Psytech Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 11, 2021

Primary Completion (ACTUAL)

April 22, 2022

Study Completion (ACTUAL)

April 22, 2022

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (ACTUAL)

May 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPL-PSILO-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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