Short Lasting Unilateral Neuralgiform Headache Attacks
Conditions
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
Interventions
DRUGPsilocybin
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
Sponsors
Beckley Psytech Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An exploratory open-label phase 1b, ascending dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\* Diagnosed with chronic SUNHA
Exclusion criteria
\* Other comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
United Kingdom
Outcome results
None listed