Phase 2 Migraine Trial, Recruiting NCT06485336 Sponsor: St. Olavs Hospital Condition: Migraine
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Phase 2 Migraine Trial, Recruiting

NCT06485336
Recruiting Phase 2

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 aged between 18 and 64 years
  • People who have given written consent to participate
  • People diagnosed with chronic migraine according to established international diagnostic guidelines (ICHD-3)
  • People who have had at least 15 headache days per month, including at least 8 migraine days per month, over the past 3 months — and this pattern must also be confirmed through a headache diary before the treatment phase begins
  • People whose migraines first started at least one year before joining the trial, based on medical records or a detailed headache history review
  • People whose migraines first began before the age of 50
  • People who are not using any other migraine prevention medications during the study
  • Women who could become pregnant must not be pregnant, must not be planning a pregnancy during the study, and must be using a highly effective form of contraception

Who may not be able to join:

  • People with medication overuse headache who need a detox program from acute medications such as triptans or opioids — although an exception may be considered for those who have already completed at least 2 months without those medications and whose opioid use is 8 days per month or fewer (confirm with trial site)
  • People who are pregnant, planning to become pregnant, unable to use contraception, or currently breastfeeding
  • People with signs or a history of liver bile flow problems (cholestasis), reduced liver function, or reduced kidney function
  • People with serious other health conditions or significant frailty that could reduce life expectancy or lead to a likely hospital stay, as assessed by the trial doctor
  • People who have a known allergy or sensitivity to statin medications, or who have taken statins before
  • People with a history of a condition called angioneurotic oedema (a type of severe swelling, often of the face or throat)
  • People who have recently stopped a migraine prevention medication less than 4 weeks before the study starts, or stopped botulinum toxin (such as Botox) less than 16 weeks before the study starts
  • People currently taking antiviral medications for hepatitis C
  • People with a significant psychiatric illness
  • People with dependence on alcohol or illicit drugs
  • People who are unable to understand the study procedures or follow them for the full duration of the trial
  • People being treated for an underactive thyroid (hypothyroidism)
  • People with lactose intolerance

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 27 July 2026
Phase 2: approximately ~30% 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: Marte-Helene Bjørk, Professor, Haukeland University Hospital

Phone: 0047 41419596

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 2
Sponsor
St. Olavs Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2024
Est. completion
31 December 2028

Where this trial is recruiting

🇳🇴 Norway

Primary endpoints

Number of migraine days

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: 27 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