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Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

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ClinicalTrials.gov Identifier: NCT04905121
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Beckley Psytech Limited

Study Description
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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)

Condition or disease Intervention/treatment Phase
Short Lasting Unilateral Neuralgiform Headache Attacks Drug: Psilocybin Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: An exploratory open-label phase 1b, ascending dose study
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Experimental: Psilocybin Drug: Psilocybin
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with treatment emergent AEs (TEAES) [ Time Frame: From first dose administered through to the last follow up visit, approximately 39 days ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Change in frequency of headache attacks [ Time Frame: From screening until the follow up visit, approximately 39 days ]
  7. Change in duration of headache attacks [ Time Frame: From screening until the follow up visit, approximately 39 days ]
  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

* Diagnosed with chronic SUNHA

Exclusion Criteria:

* Other comorbidities

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905121


Contacts
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Contact: Dr. Giorgio Lambru 0207188 3237 g.lambru@nhs.net
Contact: Dr. Manjit Matharu headache@ucl.ac.uk

Locations
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United Kingdom
King's College London Recruiting
London, United Kingdom
Contact: James Rucker, MRCPsych         
Sponsors and Collaborators
Beckley Psytech Limited
More Information
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Responsible Party: Beckley Psytech Limited
ClinicalTrials.gov Identifier: NCT04905121    
Other Study ID Numbers: BPL-PSILO-101
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Psilocybin
 Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs