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NMDA Receptor Antagonist
Ketamine for Chronic Daily Headache (KetHead Trial)
Phase 3
Recruiting
Led By Yasmine Hoydonckx, MD, FIPP
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month, 2 months and 3 months
Awards & highlights
KetHead Trial Summary
This trial 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.
Who is the study for?
This trial is for adults over 18 with chronic daily headaches, experiencing long-lasting headache episodes frequently each month. Participants must have normal liver and kidney function. It's not suitable for pregnant or breastfeeding individuals, those with renal or liver issues, certain medication users, people with severe hypertension or heart conditions, glaucoma patients, allergy to ketamine, PTSD sufferers, substance abusers or high-dose opioid users.Check my eligibility
What is being tested?
The study tests if a high-dose IV infusion of Ketamine can reduce the frequency and intensity of chronic daily headaches compared to a saline solution placebo. The effects on mood, activity levels, sleep quality and overall life satisfaction will also be evaluated over three months using questionnaires and wearable tech.See study design
What are the potential side effects?
Ketamine may cause side effects such as changes in blood pressure and heart rate; feelings of disorientation; visual disturbances; nausea; mood swings; potential bladder problems when used frequently at lower doses than studied here.
KetHead Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month, 2 months and 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month, 2 months and 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in headache days between the 2 groups
Secondary outcome measures
Impact after ketamine infusion on daily activity
Impact of ketamine infusion on analgesic consumption
Impact of ketamine infusion on patient satisfaction
+11 moreKetHead Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Ketamine infusionActive Control1 Intervention
Intravenous Ketamine
Group II: Placebo infusionPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,463 Total Patients Enrolled
The Canadian Pain SocietyOTHER
3 Previous Clinical Trials
305 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,817 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have existing liver problems.You already have kidney problems.You have high blood pressure that hasn't been treated, or you have a serious heart condition.You have an underactive thyroid.You have glaucoma.You are taking a strong CYP2B6 or CYP2C8 inhibitor at the same time.You are allergic or have a bad reaction to ketamine.You have pheochromocytoma.You are taking benzodiazepine or antipsychotic medication regularly.You have a history of stroke or other brain blood vessel problems.You have used a CGRP antagonist or Onabotulinum-toxin A within the specified time period before the infusion.You currently have been diagnosed with Post-Traumatic Stress Disorder (PTSD).You are currently diagnosed with a substance use disorder.You are taking a strong pain medication equivalent to at least 80 milligrams of oral morphine every day.You have been diagnosed with chronic daily headaches with frequent and long-lasting headaches.Your liver and kidney tests show that they are working normally.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine infusion
- Group 2: Placebo infusion
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for candidates in this research?
"Yes, this is an ongoing recruitment according to the latest update on clinicaltrials.gov. The date when the trial was first posted was June 1st, 2022, and the most recent update was on October 14th, 2022. The number of patients that the study is looking for is 56, and so far, 1 location is part of the trial."
Answered by AI
How many people are currently signed up to take part in this research?
"The trial is ongoing, as shown by the listing on clinicaltrials.gov. This particular clinical trial began on June 1st, 2022 and has thus far recruited 56 patients from a single location."
Answered by AI
Has the Ketamine infusion process been verified by the FDA?
"There is some evidence of ketamine's efficacy and multiple trials supporting its safety, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
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