Phase 3 Migraine Trial, Recruiting NCT05164172 Sponsor: H. Lundbeck A/S Condition: Migraine
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Phase 3 Migraine Trial, Recruiting

NCT05164172
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 completed the Week 12 final visit of one of two specific earlier related studies (Study 19356A or Study 19357A) immediately before enrolling in this trial.

Who may not be able to join:

  • People who experienced side effects or safety concerns during the earlier study that the trial doctor believes were caused by the study treatment and pose an ongoing safety risk.
  • People who had a severe allergic reaction (such as anaphylaxis) or another serious allergic response to the study drug infusion during the earlier study, as determined by the trial doctor.
  • People who had liver enzyme levels (ALT or AST) rise above 5 times the normal upper limit during the earlier study, confirmed by a second test taken within 2 weeks.
  • People who had liver enzyme levels (ALT or AST) rise above 3 times the normal upper limit AND a specific measure of liver function (total bilirubin) rise above 2 times the normal upper limit during the earlier 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 16 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, H. Lundbeck A/S

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
1 December 2021
Est. completion
30 April 2028

Where this trial is recruiting

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

Primary endpoints

Number of Participants With Treatment Emergent Adverse Events

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: 16 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