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NMDA Receptor Antagonist
Ketamine for Chronic Daily Headache (KetHead Trial)
Phase 3
Recruiting
Led By Yasmine Hoydonckx, MD, MSc, 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
Pivotal 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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in headache days between the 2 groups
Secondary study objectives
Impact after ketamine infusion on daily activity
Impact of ketamine infusion on analgesic consumption
Impact of ketamine infusion on patient satisfaction
+11 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Ketamine infusionActive Control1 Intervention
Intravenous Ketamine
Group II: Placebo infusionPlacebo Group1 Intervention
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,526 Previous Clinical Trials
503,216 Total Patients Enrolled
The Canadian Pain SocietyOTHER
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PfizerIndustry Sponsor
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17,860,281 Total Patients Enrolled
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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.
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