Phase 1b Study in Patients With 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).

The trial was terminated in October 2022, citing a lack of participants, though possibly related to the acquisition of Eleusis by Beckley Psytech (funder of this trial).

Topic Pain Headache Disorders
Compound Psilocybin
Country United Kingdom
Visit trial
Status Terminated
Results Published No
Start date 21 May 2021
End date 15 September 2021
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 18- 65
Therapy No

Trial Details

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

NCT Number NCT04905121

Sponsors & Collaborators

Beckley Psytech
Beckley Psytech is working on getting 5-MeO-DMT to market as the first of a variety of psychedelic medicines.

Papers

Low-dose psilocybin in short-lasting unilateral neuralgiform headache attacks: results from an open-label phase Ib ascending dose study
This open-label study (n=4) investigated the effects of low-dose oral psilocybin (5-10mg) with psychological support in patients with chronic short-lasting unilateral neuralgiform headache attacks (SUNHA). The study aimed to assess cognitive effects, safety, tolerability, and impact on headache severity and frequency, but was terminated early due to recruitment difficulties.

Data attribution

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