Phase 3 Migraine Trial, Recruiting NCT04649242 Sponsor: Pfizer Condition: Migraine
Back to Migraine

Phase 3 Migraine Trial, Recruiting

NCT04649242
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 more than 6 months before the screening appointment, confirmed by medical records and/or your own memory (or a parent's/guardian's memory).
  • You have had between 1 and 8 moderate or severe migraine attacks per month in the 2 months before joining, each attack lasting more than 3 hours without treatment, and with at least 24 hours between attacks.
  • If you are already taking a daily medication to prevent migraines, the dose has been the same for at least 12 weeks before the study starts and is not expected to change during the study (one such medication is allowed, but not a type called a CGRP antagonist — confirm with trial site).
  • If you stopped taking a preventive migraine medication before joining, you stopped at least 90 days before your screening appointment.
  • You can tell the difference between a migraine and other types of headaches.
  • You weigh more than 40 kg (about 88 pounds) at the time of screening.
  • You have accessible veins suitable for blood draws.
  • You are aged 6 years old or older but have not yet turned 18, and you will not turn 18 during the study.

Who may not be able to join:

  • You have a history of cluster headaches or a type of migraine called hemiplegic migraine.
  • You have another significant pain condition that could interfere with taking part in the study.
  • You have a mental health condition that has not been controlled or treated for at least 6 months, or you have a history of psychosis or mania.
  • You have a history of suicidal behaviour or a major mental health disorder.
  • You currently have or have a history of substance misuse, or you test positive for drugs at screening.
  • You have a history of moderate or severe head injury, a neurological condition (such as epilepsy/seizures), or a serious medical condition that is likely to affect how your brain and nervous system work.
  • You have had surgery requiring general anaesthesia within 8 weeks before screening, or you have surgery like this planned soon.
  • You have had stomach or intestinal surgery (such as gastric bypass or gastric banding) that affects how your body absorbs food and medication.
  • You have been diagnosed with viral hepatitis or have a history of liver disease.
  • You have certain serious health conditions such as uncontrolled high blood pressure, uncontrolled diabetes, or a life-threatening allergy (confirm with trial site).
  • You are currently taking a CGRP antagonist medication (such as erenumab or fremanezumab) to prevent migraines.

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 22 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
15 January 2021
Est. completion
9 January 2029

Where this trial is recruiting

🇨🇦 Canada 🇨🇳 China 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.

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: 22 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