ArticleHeadache2026
A phase 1, multicenter, open-label study to evaluate the pharmacokinetics, safety, and tolerability of a single dose of rimegepant in children (aged ≥6 to <12 years) with a history of migraine.
Article in Headache, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
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Authors and funding
10 authors.
Funding
Abstract
objectiveTo evaluate pharmacokinetics (PK), safety, and tolerability of a weight-adjusted dose of rimegepant orally disintegrating tablet (ODT) in children (aged ≥6 to <12 years) with a history of migraine.
backgroundRimegepant 75 mg ODT is approved for acute treatment of migraine (with or without aura) and preventive treatment of episodic migraine in adults. Studies of rimegepant in pediatric populations have not been conducted to date.
methodsIn this phase 1 open-label study, a single dose of rimegepant ODT was administered, based on body weight, to children aged ≥6 to <12 years. Children with body weight ≥15 kg to ≤30 kg received 25 mg (group 1; n = 7), children >30 kg to ≤50 kg received 50 mg (2 × 25 mg; group 2; n = 9), and children >50 kg received 75 mg (group 3; n = 5). Blood samples were collected pre-dose and 0.5, 1.25, 3.5, and 18 h post-dose and then analyzed using a validated bioanalytical assay. Rimegepant PK parameters, including area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC
resultsTwenty participants with ≥1 post-dose PK sample were included in PK analyses. All 21 participants treated were analyzed for safety. A majority of the study population was White (67%) and female (57%), had a median (range) age of 9.0 (6 to 11) years, and a mean (standard deviation) body weight of 37.7 (12.3) kg. Geometric mean estimates of C
conclusionsA single weight-adjusted dose of rimegepant ODT demonstrated a favorable safety profile in children aged ≥6 to <12 years with a history of migraine. Exposures in children >50 kg receiving 75 mg rimegepant were similar to observed exposures in adults receiving 75 mg. However, exposures in children >30 kg to ≤50 kg receiving 50 mg rimegepant and in children ≥15 kg to ≤30 kg receiving 25 mg rimegepant were lower than exposures in adults receiving 75 mg. These findings will be the basis for further refinement of pediatric dose in future studies.
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