Clinical TrialHeadache Disorders (Cluster & Migraine)KetamineCompleted

Proof of concept study for evaluation of the effect of ketamine intranasal spray in treatment of chronic Cluster Headache (CCH)

Open‑label, single‑arm Phase II proof‑of‑concept study (n=20) evaluating intranasal ketamine spray (sub‑anesthetic doses, product up to 75 mg) for acute treatment of chronic cluster headache in adults.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This single‑site Danish open pilot study assessed whether intranasal ketamine hydrochloride spray administered at sub‑anesthetic doses reduces acute pain in adults with chronic cluster headache (n=20).

Primary endpoint was ≥50% reduction in pain on a 0–10 NRS at 15 minutes after administration; secondary endpoints included pain at 30 minutes, proportion achieving NRS <4, need for rescue medication, patient preference versus oxygen or injectable sumatriptan, and serious adverse events.

Study Arms & Interventions

Ketamine intranasal

experimental

Intranasal ketamine spray administered in sub‑anesthetic doses for acute treatment of chronic cluster headache (single‑arm, open‑label).

Interventions

  • Ketamine
    via Other• single dose

    Intranasal spray (ketamine hydrochloride); product concentration reported up to 75 mg; administered as single sub‑anesthetic dose for acute CH attack; exact per‑dose regimen per protocol.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Signed informed consent
  • Age 18–60 years
  • Diagnosis: chronic cluster headache according to ICHD‑3 criteria
  • Body weight ≥50 kg
  • BMI ≤30

Exclusion Criteria

  • Conditions preventing completion of the experiment
  • Medical history of elevated intraocular pressure (e.g. glaucoma)
  • Severe heart or liver disease
  • Aneurysmal vascular disease or arteriovenous malformations
  • Severe neurological disease (except headache)
  • Baseline BP before attack: systolic >140 mmHg and/or diastolic >90 mmHg
  • Severe depression or psychosis
  • Previous history of drug abuse
  • Consumption of illegal drugs within the last 6 months
  • Medical history of nasal abnormality or dysfunction (e.g. rhinitis)
  • High predisposition for laryngospasm or apnoea
  • Positive pregnancy test before treatment or breastfeeding
  • Known hypersensitivity to ketamine

Study Details

Locations

Denmark

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