This placebo-controlled trial (n=56) will investigate the efficacy and safety of high-dose intravenous ketamine infusion in treating Chronic Daily Headaches (CDH) syndrome.
Conducted at Toronto Western Hospital and Sinai Health System, the study involves participants aged 18 or older with CDH lasting 4 or more hours on 15 or more days per month for 3 or more months.
The trial will administer either high-dose IV ketamine or saline infusions over six hours and assess various outcomes, including headache days, intensity, duration, sleep quality, physical activity, emotional well-being, and quality of life over three months. Participants will also use a pain and migraine diary and wear an actigraphy device to monitor their progress.
The study aims to provide valuable insights into the efficacy and safety of ketamine infusion for treating CDH.
Trial Details
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.NCT Number NCT05306899