Status:
RECRUITING
Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
The Canadian Pain Society
Pfizer
Conditions:
Chronic Daily Headache
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The KetHead study is designed as a multi-center, placebo-controlled, superiority randomized controlled trial with two parallel groups and blinding of participants and outcome assessors. It will be con...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- Pregnant or breastfeeding patients
- Pre-existing renal impairment
- Pre-existing liver impairment
- Chronic benzodiazepine or antipsychotic medication use
- History of cerebrovascular event
- Significant and untreated hypertension or severe cardiac condition
- Hypothyroidism
- Glaucoma
- Concomitant use of strong CYP2B6 or CYP2C8 inhibitor
- Allergy or intolerance to ketamine
- Pheochromocytoma
- Any significant cognitive or language barriers that impede participation
- CGRP antagonist use in 1 month or Onabotulinum-toxin A 3 months before infusion
- Active diagnosis of Post-Traumatic Stress Disorder (PTSD)
- Active diagnosis of Substance Use Disorder
- Patients taking opioid medications with daily Oral Morphine Equivalents ≥80 mg
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05306899
Start Date
June 1 2022
End Date
June 1 2026
Last Update
November 17 2025
Active Locations (2)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8