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

NCT ID: NCT04905121

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2022-04-22

Brief Summary

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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

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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

Conditions

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Short Lasting Unilateral Neuralgiform Headache Attacks

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An exploratory open-label phase 1b, ascending dose study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses

Interventions

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Psilocybin

Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\* Diagnosed with chronic SUNHA

Exclusion Criteria

\* Other comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckley Psytech Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BPL-PSILO-101

Identifier Type: -

Identifier Source: org_study_id

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