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)
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
King's College London
London, United Kingdom
Percentage of patients with treatment emergent AEs (TEAES)
Time frame: 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
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
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
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
Change in frequency of headache attacks
Time frame: 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
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
Time frame: From screening until the follow up visit, approximately 39 days
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