Phase 3 Migraine Trial, Recruiting NCT05306899 Sponsor: University Health Network, Toronto Condition: Migraine
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Phase 3 Migraine Trial, Recruiting

NCT05306899
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old
  • You have been diagnosed with chronic daily headache, meaning you have headache episodes lasting 4 or more hours that occur on 15 or more days per month, for at least 3 months in a row
  • Your liver and kidney function tests are within normal range

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You have a pre-existing kidney problem or reduced kidney function
  • You have a pre-existing liver problem or reduced liver function
  • You regularly take benzodiazepines (such as certain anxiety or sleep medications) or antipsychotic medications
  • You have previously had a stroke or similar brain blood vessel event
  • You have high blood pressure that is not being treated, or a serious heart condition
  • You have an underactive thyroid (hypothyroidism)
  • You have glaucoma (a condition affecting eye pressure)
  • You are taking certain strong medications that affect how the body processes drugs (called CYP2B6 or CYP2C8 inhibitors — confirm with trial site)
  • You have a known allergy or intolerance to ketamine
  • You have a condition called pheochromocytoma (a type of adrenal gland tumor)
  • You have significant difficulties with thinking, understanding, or communication that would make participation difficult
  • You have used certain migraine medications — specifically CGRP antagonists within the past month, or Botox (onabotulinum toxin A) within the past 3 months
  • You currently have an active diagnosis of Post-Traumatic Stress Disorder (PTSD)
  • You currently have an active diagnosis of a substance use disorder
  • You take opioid pain medications at a high daily dose (equivalent to 80 mg or more of oral morphine per day)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Anuj Bhatia, MD, PhD, University Health Network, Toronto

Phone: +1 (416) 603 5800

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 June 2022
Est. completion
1 February 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Difference in headache days between the 2 groups

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov