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Tests treatment safety and results for Chronic Daily Headache
Official title Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
ClinicalTrials.gov ID: NCT05306899
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for chronic daily headache.
Also referred to as Ketamine hydrochloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Normal liver and kidney function tests
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.