Phase 3 Migraine Trial, Recruiting NCT05897320 Sponsor: H. Lundbeck A/S Condition: Migraine
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Phase 3 Migraine Trial, Recruiting

NCT05897320
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:

  • People who have been diagnosed with migraine (with or without aura) for at least 6 months before the screening visit, based on recognised international headache diagnosis guidelines.
  • People who consistently fill in a daily headache diary on an electronic device for at least 23 out of 28 days during the screening period.
  • People who, during that same 28-day screening period, have no more than 14 days with headaches, and at least 4 of those days are migraine days as recorded in the diary.

Who may not be able to join:

  • People with a history or diagnosis of certain other headache types, such as chronic tension-type headache, cluster headache, hypnic headache, or specific less common migraine types including hemiplegic migraine or migraine with brainstem aura, among others (confirm with trial site for the full list).
  • People with a history of moderate or severe head injury, or another neurological or serious medical condition that, in the doctor's opinion, is likely to affect how the brain and nervous system work.
  • People with a current mental health condition that has not been managed or treated for at least 6 months before the screening visit, or people who have ever had a history of psychosis or mania.
  • People with any other medical condition where treating that condition would need to take priority over treating migraine, or where the condition might interfere with taking part in the study.

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 23 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: Email contact via H. Lundbeck A/S, HQ_Medinfo@Lundbeck.com

Phone: +45 36301311

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
Sponsor
H. Lundbeck A/S
Registry
ClinicalTrials.gov
Start date
8 June 2023
Est. completion
6 July 2027

Where this trial is recruiting

🇦🇷 Argentina 🇨🇦 Canada 🇮🇹 Italy 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇸 Serbia 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

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: 23 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