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

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Short Lasting Unilateral Neuralgiform Headache Attacks

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: * Diagnosed with chronic SUNHA Exclusion Criteria: * Other comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An exploratory open-label phase 1b, ascending dose study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psilocybin<br> | Drug: Psilocybin<br>* Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in intensity of headache attacks | 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 |