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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Rimegepant for Migraine

This study wants to compare the how well it works and safety of rimegepant to dummy treatment (placebo) as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

Official registry: https://clinicaltrials.gov/study/NCT05156398 · Pfizer · enrollment listed as 640

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rimegepant, or Placebo. The registry lists allocation as randomized. This study wants to compare the how well it works and safety of rimegepant to dummy treatment (placebo) as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

They plan to enroll about 640 people at 93 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

Interventions: Rimegepant, Placebo

Primary outcome (registry wording): 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

Who it is for (from inclusion criteria)

  • Ages 6 Years to 17 Years
  • Subject has at least a 6 month history of migraine (with or without aura) and including the following:
  • 14 or less headache days per month during the 3 month period prior to the Screening Visit
  • 6 or more migraine days during the Observation Period
  • 14 or less headache days during the Observation Period
  • Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
  • Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
  • Migraine attacks, on average, lasting 4 - 72 hours if untreated

Public study contact (from the registry)

Pfizer Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

93 listed

+ 37 sites outside the US on the same record

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT05156398 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05156398?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05156398?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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