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

Phase 1

Terminated

• Conditions: Short Lasting Unilateral Neuralgiform Headache Attacks
• Interventions: Drug: Psilocybin

• Registration Number: NCT04905121
• Lead Sponsor: Beckley Psytech Limited

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)

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 Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2021-08-11
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

* Diagnosed with chronic SUNHA

Exclusion Criteria

* Other comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psilocybin	Psilocybin	-

Primary Outcome Measures

Name	Time	Method
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 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
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
Change in intensity 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
Change in duration of headache attacks	From screening until the follow up visit, approximately 39 days

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom