Overview

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

Status:
Not yet recruiting
Trial end date:
2024-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Collaborators:
Pfizer
The Canadian Pain Society
Treatments:
Ketamine
Criteria
Inclusion Criteria:

1. Age 18 years or older

2. CDH diagnosis preceding trial enrollment with headache episodes lasting for 4 or more
hours occurring on 15 or more days in a month for 3 or more months (ICHD-3 criteria)

3. Normal liver and kidney function tests

Exclusion criteria:

1. Pregnant or breastfeeding patients

2. Pre-existing renal impairment

3. Pre-existing liver impairment

4. Chronic benzodiazepine or antipsychotic medication use

5. History of cerebrovascular event

6. Significant and untreated hypertension or severe cardiac condition

7. Hypothyroidism

8. Glaucoma

9. Concomitant use of strong CYP2B6 or CYP2C8 inhibitor

10. Allergy or intolerance to ketamine

11. Pheochromocytoma

12. Any significant cognitive or language barriers that impede participation

13. CGRP antagonist use in 1 month or Onabotulinum-toxin A 3 months before infusion

14. Active diagnosis of Post-Traumatic Stress Disorder (PTSD)

15. Active diagnosis of Substance Use Disorder

16. Patients taking opioid medications with daily Oral Morphine Equivalents ≥80 mg