Study Stopped
Unable to recruit patient population
Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
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)
1 other identifier
interventional
4
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
August 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedOctober 12, 2022
October 1, 2022
8 months
May 6, 2021
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
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
Study Arms (1)
Psilocybin
EXPERIMENTALInterventions
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
Eligibility Criteria
You may qualify if:
- \* Diagnosed with chronic SUNHA
You may not qualify if:
- \* Other comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College London
London, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 27, 2021
Study Start
August 11, 2021
Primary Completion
April 22, 2022
Study Completion
April 22, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.