NCT05306899 Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
| NCT ID | NCT05306899 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Chronic Daily Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 56 participants in total. It began in 2022-06-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Anuj Bhatia, MD, PhD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05306899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Daily Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05306899 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 56 participants.
Is NCT05306899 currently recruiting?
Yes, NCT05306899 is actively recruiting participants. Contact the research team at KetHead@uhn.ca for enrollment information.
Where is the NCT05306899 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT05306899 clinical trial?
NCT05306899 is sponsored by University Health Network, Toronto. The principal investigator is Anuj Bhatia, MD, PhD at University Health Network, Toronto. The trial plans to enroll 56 participants.