Phase 1b study of BPI-PSILO on cognition in patients with SUNHA

• Research type

  Research Study

• Full 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)

• IRAS ID

  290661

• Contact name

  Kalpana Sawant

• Contact email

  kalpana@beckleypsytech.com

• Sponsor organisation

  Beckley Psytech Limited

• Eudract number

  2020-005094-28

• Duration of Study in the UK

  0 years, 6 months, 31 days

• Research summary

  This research study is being carried out to see what affects the study drug, BPL-PSILO (psilocybin), may have on the cognition of patients who have chronic short-lasting unilateral neuralgiform headache attacks (SUNHA). Cognition is the mental processes of thinking, awareness, perception, reasoning and judgement. The study will also look at whether BPL-PSILO has any effect on reducing incidence, number and intensity of SUNHA attacks.
  There are no approved treatments for SUNHA and patients currently rely on off-label (not approved for treatment of SUNHA) treatments to help manage the condition such as anti-epileptic drugs (e.g. lamotrigine & gabapentin), greater occipital nerve blocks (when pain medication is injected near the occipital nerve to relieve pain) and oral steroids.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  20/LO/1232

• Date of REC Opinion

  18 Jan 2021

• REC opinion

  Further Information Favourable Opinion