Phase 4 Migraine Trial, Completed NCT05452239 Sponsor: H. Lundbeck A/S Condition: Migraine
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial enrolled around 608 participants (approximately 305 in the eptinezumab group and 303 in the placebo group). The trial was looking at people with chronic migraine and was measuring changes in the number of migraine days per month over a placebo-controlled period, followed by an open-label period where everyone received the active treatment. The main thing being tracked was how many migraine days per month participants experienced compared to where they started. The reported data shows that, for the primary outcome — change in migraine days per month over the first four weeks — the eptinezumab group reported a reduction of about 6.85 days per month, while the placebo group reported a reduction of about 3.66 days per month. Over the full 12-week placebo-controlled period, the reported reductions were 7.44 days per month for the eptinezumab group and 4.50 days per month for the placebo group. The reported data also shows that around 37.8% of the eptinezumab group (compared to 18.1% in the placebo group) no longer met the clinical criteria for chronic migraine or medication overuse headache at weeks 1–4, with similar patterns reported at weeks 1–12. Reductions in general headache days per month and in days using acute migraine medications were also reported for both groups, with larger reductions seen in the eptinezumab group across all these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Migraine Trial, Completed

NCT05452239
Completed Phase 4 🇦🇺 Australian site

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 have been diagnosed with migraine or medication overuse headache, confirmed by a doctor using established guidelines at a screening visit.
  • You have had at least 8 migraine days per month, every month, for the past 3 months.
  • You have had at least 15 headache days per month, every month, for the past 3 months.
  • You were first diagnosed with migraine at age 50 or younger.

Who may not be able to join:

  • You have other significant ongoing pain conditions, such as fibromyalgia, chronic lower back pain, or complex regional pain syndrome.
  • You have been diagnosed with an active jaw joint disorder (such as temporomandibular disorder).
  • You have a history of certain other headache types, such as chronic tension-type headache, cluster headache, or certain less common migraine types involving weakness, double vision, or loss of consciousness (confirm with trial site).
  • You have an uncontrolled mental health condition such as psychosis, bipolar mania, or dementia, or you have not been receiving adequate treatment for such a condition for at least 6 months before the screening visit.
  • You have a history of significant heart or blood vessel problems, such as uncontrolled high blood pressure, poor blood flow to tissues, or blood clots (such as stroke, deep vein thrombosis, or pulmonary embolism).

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

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

Australian sites

Southern Neurology, Kogarah, New South Wales
Mater Adult Hospital, South Brisbane, Queensland
Austin Hospital, Heidelberg, Victoria
Alfred Health, Melbourne, Victoria
Royal Melbourne Hospital, Parkville, Victoria

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
H. Lundbeck A/S
Registry
ClinicalTrials.gov
Start date
1 July 2022
Est. completion
22 October 2024

Where this trial is recruiting

🇦🇺 Australia 🇩🇰 Denmark 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇪🇸 Spain 🇸🇪 Sweden 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4

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