Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
RecruitingPhase 3NCT05306899
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Brief summary (from the registry)
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.
Study details
- Official title
- A Multi-center Randomized Controlled Trial of Efficacy and Safety of Intravenous Ketamine for Chronic Daily Headaches: The KetHead Study
- Conditions
- Chronic Daily Headache
- Interventions
- Drug: Ketamine
- Other: 0.9% Saline
- Sponsor
- University Health Network, Toronto
- Collaborators
- The Canadian Pain Society; Pfizer
- Start date
- 2022-06-01
- Primary completion
- 2027-02-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age 18-75 years 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 (International Headache Society-IHS 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
Canadian sites (2)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05306899