Clinical TrialHeadache Disorders (Cluster & Migraine)KetaminePlaceboCompleted

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

This prospective, randomised, open-label trial (n=5) compared the analgesic efficacy and safety of a proprietary oral aspirin+ketamine formulation (AOK; ketamine 0.85 mg/kg + aspirin 324 mg) to Nurtec (rimegepant 75 mg ODT) in adult ED patients with acute headache.

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Target Enrollment
5 participants
Study Type
Phase IV interventional
Design
Randomized

Detailed Description

Prospective, randomised, open-label equivalence trial in ED patients (n=5) comparing AOK (ketamine 0.85 mg/kg plus aspirin 324 mg) to rimegepant 75 mg ODT; primary outcome is change in pain NRS at 60 minutes.

Secondary outcomes include need for rescue analgesia and rates of adverse effects up to 120 minutes; dissociative and agitation scales (SERSDA, RASS) and vital signs are used for safety monitoring.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

AOK (ketamine + aspirin)

experimental

Proprietary oral formulation of ketamine 0.85 mg/kg with aspirin 324 mg given as single oral dose in ED patients.

Interventions

  • Ketamine0.85 mg/kg
    via Oral• single dose

    Co-formulated with aspirin 324 mg.

Nurtec (Rimegepant)

active comparator

Rimegepant 75 mg orally disintegrating tablet (ODT) single dose comparator.

Interventions

  • Placebo75 mg
    via Oral• single dose

    Nurtec (rimegepant) 75 mg ODT (active comparator encoded as placebo reference)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients age 18 and older
  • Acute Headache (lasting no more than 1 week)
  • Initial pain score of 5 or more on a standard 11-point (0 to 10) numeric rating scale
  • Awake, alert, and oriented to person, place, and time
  • Requires oral analgesia as determined by treating physician

Exclusion Criteria

  • Exclusion Criteria:
  • Altered mental status
  • Allergy to aspirin, ketamine, or rimegepant
  • Pregnancy or breastfeeding
  • Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/min, respiration rate <10 or >30 breaths/min)
  • Inability to provide consent
  • Consumption of aspirin or NSAIDs within 6 hours of arrival or acetaminophen within 4 hours of arrival
  • Active peptic ulcer disease
  • History of GI haemorrhage
  • History of renal or hepatic insufficiency
  • Past medical history of alcohol or drug abuse
  • Schizophrenia
  • Clinical findings concerning for acute intracranial process or acute infectious process

Study Protocol, Arms & Participants

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Study Details

Locations

Maimonides Medical Center — Brooklyn, New York, United States

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