Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05306899

Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches

Led by University Health Network, Toronto · Updated on 2026-02-05

56

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

T

The Canadian Pain Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic daily headaches (CDH) poses a significant burden on patients, healthcare systems and the society. Intravenous (IV) ketamine infusion, an intervention that is widely available and scalable, can treat CDH by reversing receptor-mediated sensitization. This study is a multicenter, placebo-controlled, parallel group randomized trial with blinding of participants and observers with the goal of comprehensively assessing the effect of high-dose IV ketamine infusion (1 mg.kg-1.h-1 for six hours) on the frequency and intensity of headaches, mood, activity, sleep, quality of life and safety of ketamine for three months after the interventions. Use of validated questionnaires, wearable technology, a research team that includes investigators with expertise in studying ketamine and in evaluating treatments for CDH and pain syndromes are some of the unique features of this project. Our study aims to prospectively assess the efficacy and safety of high-dose intravenous ketamine infusions compared to saline infusions in participants with CDH syndrome.

CONDITIONS

Official Title

Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Diagnosis of chronic daily headache with episodes lasting 4 or more hours on 15 or more days per month for at least 3 months
  • Normal liver and kidney function tests
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Pre-existing kidney impairment
  • Pre-existing liver impairment
  • Regular use of benzodiazepine or antipsychotic medications
  • History of cerebrovascular event
  • Significant untreated high blood pressure or severe heart condition
  • Hypothyroidism
  • Glaucoma
  • Use of strong CYP2B6 or CYP2C8 inhibitors
  • Allergy or intolerance to ketamine
  • Pheochromocytoma
  • Significant cognitive or language barriers
  • Use of CGRP antagonists within 1 month or Onabotulinum-toxin A within 3 months before infusion
  • Active post-traumatic stress disorder
  • Active substance use disorder
  • Daily opioid use with oral morphine equivalents of 80 mg or more

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Women's College Hospital

Toronto, Ontario, Canada, M5S 1B2

Actively Recruiting

2

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

Loading map...

Research Team

E

Emad Al Azazi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here