Migraine Trial, Recruiting NCT06554886 Sponsor: St. Olavs Hospital Condition: Migraine
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Migraine Trial, Recruiting

NCT06554886
Recruiting Not Applicable

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:

  • People who are 18 years of age or older at the time of signing the consent form
  • People who have been diagnosed with chronic migraine (with or without aura) according to international headache classification standards, confirmed by a neurologist
  • People who have had at least 8 severely debilitating headache days per month for at least 3 months in a row, where headaches seriously interfere with daily activities even after taking pain-relief medication at the recommended dose and taken early in the attack — and where at least two different triptan medications have not worked
  • People who have had chronic migraine for at least 1 year before joining the trial
  • People whose episodic migraines began before age 50, and whose chronic migraines began before age 65
  • People whose migraines have not responded well to at least 3 of the following medication types (due to lack of effectiveness, side effects, or medical reasons why they cannot take them): certain antidepressants, certain anti-epileptic drugs, beta-blockers, calcium channel blockers, CGRP-targeting medications, certain blood pressure medications, or Botox injections
  • People who have not changed their preventive headache medications (type, dose, or frequency) in the 3 months before the study begins
  • People who have not used steroid tablets or steroid injections for more than 8 weeks before the study begins, and who agree to avoid these during the study and for 8 weeks after the procedure (steroid inhalers or skin treatments are not included in this restriction)
  • People who agree to keep their current preventive headache medication regimen unchanged during the study and for 8 weeks after the procedure
  • People whom the treating investigator considers a suitable candidate for the procedure involved in this study
  • People who are able to understand and agree to the study requirements outlined in the consent form

Who may not be able to join:

  • People who cannot tell the difference between their migraines and other types of headaches they experience
  • People who have headaches caused by another underlying condition (though medication overuse headache is an exception)
  • People who, in the investigator's opinion, have shown no or very little response to more than 6 adequate trials across the preventive medication categories listed above
  • People who have changed their preventive headache medications during the baseline period of the study
  • People with a current problem with drug (including narcotic) or alcohol misuse
  • People who use opioid medications (such as codeine or tramadol) on more than 4 days per month, or who use any barbiturate medications
  • People with other ongoing pain conditions that, in the investigator's opinion, could interfere with study procedures or make it difficult to assess results accurately
  • People with other medical conditions that, in the investigator's opinion, are likely to worsen and could affect how results are measured
  • People with existing medical conditions — such as bleeding or clotting disorders — that, in the investigator's opinion, would make the procedure carry too much risk
  • People with significant psychological conditions, unusual pain responses, or inappropriate medication use that, in the investigator's opinion, could affect pain perception, ability to follow the study protocol, or ability to assess treatment outcomes
  • People with a physical abnormality or prior injury that would make the planned procedure difficult to carry out
  • People who currently have an active abscess or local infection at the site where the procedure would be performed
  • People who have had a serious infection such as bone infection, or a cancer affecting the skull or procedure site, that has been active or required treatment in the past 6 months
  • People who have any type of implanted electrical device that is not compatible with nerve stimulation
  • People who are not able to give informed consent themselves

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 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Daniel F Bratbak, PhD, St. Olavs Hospital

Phone: 004792029956

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
Not Applicable
Sponsor
St. Olavs Hospital
Registry
ClinicalTrials.gov
Start date
29 August 2024
Est. completion
31 January 2026

Where this trial is recruiting

🇳🇴 Norway

Primary endpoints

Headache days - severe and moderate; Safety - AE and SAE

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: 21 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