Evidence map›Paper›PMID 41133912›Full record

Trial reportEpilepsia2026

Bexicaserin for the treatment of seizures in developmental and epileptic encephalopathies: A phase 1b/2a trial (PACIFIC).

Dennis J Dlugos, Ingrid E Scheffer, Jacqueline A French, David G Vossler, Chad Orevillo, Shikha Polega, Randall Kaye, and the LP352‐201 Study Investigators

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Epilepsia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Dennis J DlugosChildren's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0003-3088-7645
Ingrid E SchefferEpilepsy Research Centre, University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.ORCID https://orcid.org/0000-0002-2311-2174
Jacqueline A FrenchNew York University Grossman School of Medicine, New York, New York, USA.ORCID https://orcid.org/0000-0003-2242-8027
David G VosslerUniversity of Washington School of Medicine, Seattle, Washington, USA.ORCID https://orcid.org/0000-0003-4823-0537
Chad OrevilloLongboard Pharmaceuticals (now part of H. Lundbeck A/S), La Jolla, California, USA.ORCID https://orcid.org/0009-0003-4220-2508
Shikha PolegaH. Lundbeck A/S, Copenhagen, Denmark.ORCID https://orcid.org/0009-0009-7680-4789
Randall KayeLongboard Pharmaceuticals (now part of H. Lundbeck A/S), La Jolla, California, USA.ORCID https://orcid.org/0000-0001-6703-7287
and the LP352‐201 Study Investigators

Funding

Funded by Longboard Pharmaceuticals (now a part of H. Lundbeck A/S)
6 · The paper itself

Abstract

objectiveThis randomized, double-blind, phase 1b/2a clinical trial was designed to evaluate the safety, tolerability, and efficacy of oral bexicaserin versus placebo for the treatment of seizures in adolescents and adults with developmental and epileptic encephalopathies (DEEs).

methodsEligible participants had a DEE diagnosis, were aged 12-65 years, and were taking 1-4 concomitant antiseizure medications. Randomization to treatment groups (4:1 bexicaserin:placebo) was stratified by type of DEE (Dravet syndrome [DS], Lennox-Gastaut syndrome [LGS], or DEE Other). Following a 28-day baseline period, the treatment period consisted of a 15-day flexible uptitration period (6, 9, or 12 mg three times daily, 5 days each) and a 60-day maintenance period on the highest tolerated dose. Primary end points were safety (adverse events) and change from baseline in countable motor seizure frequency.

resultsForty-three and nine participants were assigned to bexicaserin treatment and placebo, respectively, and received ≥1 dose (safety set); 35 bexicaserin and nine placebo participants completed titration, entered the maintenance period, and had ≥1 seizure measurement during the maintenance period (full analysis set). Twenty-eight of 43 bexicaserin-treated participants (65.1%) and three of nine (33.3%) in the placebo group reported drug-related treatment-emergent adverse events (TEAEs); seven of 43 participants (16.3%) discontinued bexicaserin due to a TEAE during titration and two of 43 (4.7%) during maintenance, most frequently due to somnolence. Median reductions in countable motor seizure frequencies were -59.8% with bexicaserin and -17.4% with placebo; reductions with bexicaserin were observed across DEEs (DS, -74.6%; LGS, -50.8%; DEE Other, -65.5%). The proportion of participants achieving ≥50% reductions during the treatment period (responder analysis) was 60.0% with bexicaserin versus 33.3% with placebo. SIGNIFICANCE: Bexicaserin was well tolerated and associated with clinically relevant reductions in countable motor seizure frequencies in participants with a variety of DEEs. This novel trial design may expand treatment access to patients previously excluded from clinical trials.

Indexed as

AnticonvulsantsSeizuresAdolescentAdultAgedChildDose-Response Relationship, DrugDouble-Blind MethodEpilepsies, MyoclonicFemaleHumansLennox Gastaut SyndromeMaleMiddle AgedTreatment OutcomeYoung AdultAnticonvulsantsbexicaserindevelopmental and epileptic encephalopathiesseizuresserotonin

Identifiers

PMID41133912
PMCPMC12927688

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.