Clinical TrialHeadache Disorders (Cluster & Migraine)PsilocybinTerminated

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

This exploratory open-label Phase Ib, ascending dose study evaluates the effects of psilocybin on cognition in patients with chronic SUNHA.

Target Enrollment
4 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label Phase 1b single-group study administering psilocybin in three ascending oral doses to patients with chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA).

Primary aims are safety and tolerability; secondary aims include effects on cognition and exploratory change in attack frequency, duration, and intensity.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Open-label, single-group ascending-dose psilocybin capsules, three dose levels.

Interventions

  • Psilocybin
    via Oral• ascending doses• 3 doses total

    Dry-filled capsules administered orally in three ascending single-dose sessions.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosed with chronic SUNHA

Exclusion Criteria

  • Exclusion Criteria:
  • Other comorbidities

Study Details

Locations

King's College London — London, United Kingdom

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