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NCT05133323 · ClinicalTrials.gov registry record · Phase 2

A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

A Phase 2 study, sponsored by H. Lundbeck A/S.

Completed
Registry status
Phase 2
Development phase
237
Enrollment target

NCT05133323: Completed Phase 2 study, sponsored by H. Lundbeck A/S.

NCT05133323 is a Phase 2 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05133323, a Phase 2 study, has completed, sponsored by H. Lundbeck A/S.

COMPLETED
Registry status
Phase 2
Development phase
237 participants
Enrollment target

Study Summary

Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.

Primary Outcome

The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that: * lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura * or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with

Interventions

  • DRUG Placebo
  • DRUG Lu AG09222

Trial Details

FieldValue
Enrollment Target 237 participants
Start Date 2021-11-11
Est. Completion 2023-03-16
Phase Phase 2
H. Lundbeck A/S

72 total trials

What the finished NCT05133323 record still lists

NCT05133323 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05133323 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05133323 about?

NCT05133323 is a clinical study titled "A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments". Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medic...

What is the current status of trial NCT05133323?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2021-11-11. Estimated completion is 2023-03-16.

What interventions are being tested in trial NCT05133323?

The interventions under investigation include: Placebo (DRUG), Lu AG09222 (DRUG).

Who is sponsoring clinical trial NCT05133323?

This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05133323's enrollment target sits among peer trials

237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05133323, the US trial registry maintained by the National Library of Medicine. NCT05133323 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.