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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

Tracking Information
First Submitted Date  ICMJE May 6, 2021
First Posted Date  ICMJE May 27, 2021
Last Update Posted Date April 11, 2022
Actual Study Start Date  ICMJE August 11, 2021
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2021)
  • Percentage of patients with treatment emergent AEs (TEAES) [ Time Frame: From first dose administered through to the follow up visit, approximately 16 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 30 days ]
  • Change in duration of headache attacks [ Time Frame: From screening until the follow up visit, approximately 30 days ]
  • Change in intensity of headache attacks [ Time Frame: From screening until the follow up visit, approximately 30 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Official Title  ICMJE 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)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Short Lasting Unilateral Neuralgiform Headache Attacks
Intervention  ICMJE Drug: Psilocybin
Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
Study Arms  ICMJE Experimental: Psilocybin
Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2021)		 12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

* Diagnosed with chronic SUNHA

Exclusion Criteria:

* Other comorbidities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr. Giorgio Lambru 0207188 3237 g.lambru@nhs.net
Contact: Dr. Manjit Matharu headache@ucl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04905121
Other Study ID Numbers  ICMJE BPL-PSILO-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Beckley Psytech Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beckley Psytech Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beckley Psytech Limited
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP