Using IV Ketamine to Treat Chronic Daily Headaches
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Intravenous Ketamine for Chronic Daily Headaches: The KetHead Study
This study is testing if high-dose IV ketamine can help people with chronic daily headaches feel better and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05306899 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of high-dose intravenous ketamine infusions for patients suffering from chronic daily headaches. It is a multicenter, placebo-controlled, randomized trial that includes blinding of participants and assessors to ensure unbiased results. Participants will receive either ketamine or a placebo while being monitored by anesthesiologists, and their headache frequency, intensity, mood, activity, sleep, and quality of life will be assessed over three months. The study aims to provide comprehensive data on the potential benefits of ketamine for chronic pain management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of chronic daily headache lasting for 4 or more hours on 15 or more days per month.
Not a fit: Patients with pre-existing renal or liver impairments, significant cardiovascular conditions, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency and intensity of chronic daily headaches, improving patients' quality of life.
How similar studies have performed: Previous studies have shown promising results with ketamine for chronic pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario and 1 other locations
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Anuj Bhatia, MD, PhD — University Health Network, Toronto
- Study coordinator: Emad Al Azazi
- Email: KetHead@uhn.ca
- Phone: +1 (416) 603 5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.