Phase 3 Migraine Trial, Recruiting NCT05156398 Sponsor: Pfizer Condition: Migraine
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Phase 3 Migraine Trial, Recruiting

NCT05156398
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:

  • You have had migraines (with or without aura) for at least 6 months
  • You had 14 or fewer headache days per month in the 3 months before the screening visit
  • You had 6 or more migraine days during the observation period at the start of the study
  • You had 14 or fewer total headache days during that same observation period
  • Your migraines cause mild to moderate disruption to your daily activities, based on a standard questionnaire score (confirm with trial site)
  • You can tell the difference between your migraines and other types of headaches, such as tension headaches
  • Your migraine attacks typically last between 4 and 72 hours if you do not take any treatment
  • If you are already taking medication to prevent migraines, you may still be eligible as long as the dose has been the same for at least 3 months and is not expected to change during the study
  • You are between 6 and 17 years old (you must be under 18 at the time of signing the consent form)
  • You weigh at least 40 kg (or at least 15 kg for younger children — confirm with trial site)

Who may not be able to join:

  • You have a history of certain specific types of migraine, including basilar migraine, cluster headaches, or hemiplegic migraine
  • You had a continuous, non-stop headache in the month before the screening visit
  • You have a history of known complications from migraines
  • You have another significant ongoing pain condition that could interfere with taking part in the study
  • You have a psychiatric condition that has not been managed or treated for at least 6 months, or you have ever been diagnosed with psychosis or mania
  • You have a history of suicidal behaviour, or there is concern that you may be at risk of harming yourself or others
  • You have a history of a major psychiatric disorder
  • You currently have or have a history of substance abuse
  • You have a history of moderate or severe head injury, a seizure disorder, or another significant neurological or serious medical condition that could affect how your brain and nervous system work

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 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: Pfizer CT.gov Call Center, Pfizer

Phone: 1-800-718-1021

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
Registry
ClinicalTrials.gov
Start date
28 February 2022
Est. completion
29 November 2031

Where this trial is recruiting

🇨🇦 Canada 🇫🇷 France 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine

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