Not provided
Not provided
Not provided
Not provided
Not provided
Unable to recruit patient population
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
* Diagnosed with chronic SUNHA
Exclusion Criteria:
* Other comorbidities
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | United Kingdom |
Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
Not provided
Not provided
An exploratory open-label phase 1b, ascending dose study
Not provided
Not provided
Not provided
Not provided
| From screening until the follow up visit, approximately 39 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |