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

Beckley Psytech

Status and phase: Terminated; Phase 1

Conditions: Short Lasting Unilateral Neuralgiform Headache Attacks

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04905121

BPL-PSILO-101

Details and patient eligibility

About

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)

Full 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

Enrollment: 4 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

* Diagnosed with chronic SUNHA

Exclusion criteria

* Other comorbidities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Psilocybin

Experimental group

Treatment:

Drug: Psilocybin