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Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches

Study acronym: KetHead
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Feb 1, 2026 to Feb 1, 2027 Completion pushed from Jun 1, 2026 to Jun 1, 2027v8 Show 1 more changeShow less
    • Completion pushed from Jun 1, 2026 to Jun 1, 2027
  2. Site details revised at 2 of 2 sitesv7
  3. Primary completion date: Oct 1, 2025 to Feb 1, 2026 Completion date: Feb 1, 2026 to Jun 1, 2026 · Site contacts updated at 1 of 2 sitesv6 Show 2 more changesShow less
    • Completion date: Feb 1, 2026 to Jun 1, 2026
    • Site contacts updated at 1 of 2 sites
  4. Primary completion date: Oct 1, 2023 to Oct 1, 2025 Study sites: 1 to 2 · Completion date: Feb 1, 2024 to Feb 1, 2026 · Eligibility criteria shortened, about 2 wordsv5 Show 3 more changesShow less
    • Study sites: 1 to 2
    • Completion date: Feb 1, 2024 to Feb 1, 2026
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Apr 1, 2022 to Jun 1, 2022 Eligibility criteria expanded, about 2 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05306899
Lead Sponsor University Health Network, Toronto
Collaborators: The Canadian Pain Society, Pfizer
Conditions Chronic Daily Headache
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov