Short Lasting Unilateral Neuralgiform Headache AttacksPhase 1NCT04905121
Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
A Phase 1 study testing Psilocybin in people with Short Lasting Unilateral Neuralgiform Headache Attacks, run by Beckley Psytech Limited at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Short Lasting Unilateral Neuralgiform Headache Attacks
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2021to 22 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic SUNHA
Who cannot join
- Other comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)
Read the 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
- Being tested
- Psilocybin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Not described Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with treatment emergent AEs (TEAES)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From first dose administered until the las dose administered, approximately 11 days
Change in frequency of headache attacks
Measured: From screening until the follow up visit, approximately 39 days
Change in duration of headache attacks
Measured: 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
Measured: From screening until the follow up visit, approximately 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start11 Aug 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Why it stopped: Unable to recruit patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Lasting Unilateral Neuralgiform Headache AttacksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An exploratory open-label phase 1b, ascending dose study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckley Psytech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905121
- Sponsor's protocol ID
- BPL-PSILO-101
- Status last verified
- Oct 2022
- First submitted
- 6 May 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04905121
- Acronym / sponsor ID
- BPL-PSILO-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patient population
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Beckley Psytech LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An exploratory open-label phase 1b, ascending dose study
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with chronic SUNHA
Key exclusion criteria (1 listed)
- Other comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses | Drug | Psilocybin |
Primary outcome
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
Time frame: 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
Results and safety
The study was stopped early (reason given: Unable to recruit patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No. Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Short Lasting Unilateral Neuralgiform Headache Attacks, run by Beckley Psytech Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit patient population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with treatment emergent AEs (TEAES) (time frame: From first dose administered through to the last follow up visit, approximately 39 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.