Back to resultsPhase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Primary Purpose
Short Lasting Unilateral Neuralgiform Headache Attacks
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
About this trial
This is an interventional treatment trial for Short Lasting Unilateral Neuralgiform Headache Attacks
Eligibility Criteria
Inclusion Criteria:
* Diagnosed with chronic SUNHA
Exclusion Criteria:
* Other comorbidities
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psilocybin
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with treatment emergent AEs (TEAES)
Treatment-related changes in Paired Associates Learning (PAL) scores and evaluation of dose response
Treatment-related changes in Spatial Working Memory (SWM) scores and evaluation of dose response
Treatment-related changes in Reaction Time Index (RTI) scores and evaluation of dose response
Treatment-related changes in Rapid Visual Information Processing (RVP) scores and evaluation of dose response
Change in frequency of headache attacks
Change in duration of headache attacks
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905121
Brief Title
Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit patient population
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beckley Psytech Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Lasting Unilateral Neuralgiform Headache Attacks
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
An exploratory open-label phase 1b, ascending dose study
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psilocybin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
Primary Outcome Measure Information:
Title
Percentage of patients with treatment emergent AEs (TEAES)
Time Frame
From first dose administered through to the last follow up visit, approximately 39 days
Title
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
Title
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
Title
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
Title
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
Title
Change in frequency of headache attacks
Time Frame
From screening until the follow up visit, approximately 39 days
Title
Change in duration of headache attacks
Time Frame
From screening until the follow up visit, approximately 39 days
Title
Change in intensity of headache attacks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
* Diagnosed with chronic SUNHA
Exclusion Criteria:
* Other comorbidities
Facility Information:
Facility Name
King's College London
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
Learn more about this trial
Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
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