NCT05306899RecruitingPhase 3
Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Intravenous Ketamine for Chronic Daily Headaches: The KetHead Study
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 2 Mar 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Migraine
- NCT number
- NCT05306899
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 56
- From 1 Jun 2022 to the primary completion date, 1 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic benzodiazepine or antipsychotic medication use
- Concomitant use of strong CYP2B6 or CYP2C8 inhibitor
- CGRP antagonist use in 1 month or Onabotulinum-toxin A 3 months before infusion
- Patients taking opioid medications with daily Oral Morphine Equivalents ≥80 mg
Other illness
- Pre-existing renal impairment
- Pre-existing liver impairment
- History of cerebrovascular event
- Significant and untreated hypertension or severe cardiac condition
- Allergy or intolerance to ketamine
- Active diagnosis of Post-Traumatic Stress Disorder (PTSD)
- Active diagnosis of Substance Use Disorder
Other
- Pregnant or breastfeeding patients
- Hypothyroidism
- Glaucoma
- Pheochromocytoma
- Any significant cognitive or language barriers that impede participation
Who the study is looking for
- Age 18-75 years
- 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)
- Normal liver and kidney function tests
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.