Evidence map›Paper›PMID 37965170›Full record

ArticleFrontiers in neurology2023

Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience.

Andrew Blumenfeld, Stewart J Tepper, Rashna Khanna, Erin Doty, Maurice Vincent, Sheila I Miller

4 registry-linked trialsAbstract read
In one paragraph

Article in Frontiers in neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT00384774 phase2completednot on this map

A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine

TypeinterventionalSponsorEli Lilly and CompanyRan2006 to 2007Enrolled130ConditionsMigraineArmsLasmiditan, Placebo
NCT00883051 phase2completednot on this map

A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

TypeinterventionalSponsorEli Lilly and CompanyRan2009 to 2010Enrolled512ConditionsMigraine DisordersArmsLasmiditan, Placebo
NCT02565186 phase3completednot on this map

An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2019Enrolled2,171ConditionsMigraine DisordersArmsLasmiditan
NCT03670810 phase3completednot on this map

Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2021Enrolled1,633ConditionsMigraineArmsLasmiditan, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Serotonin syndrome controversies: A need for consensus.World journal of critical care medicine · 2024
    Review
  2. Article
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

6 authors.

Andrew BlumenfeldThe Neurology Center of Southern California, Carlsbad, CA, United States.
Stewart J TepperGeisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.
Rashna KhannaEli Lilly and Company, Bracknell, United Kingdom.
Erin DotyEli Lilly and Company, Indianapolis, IN, United States.
Maurice VincentEli Lilly and Company, Indianapolis, IN, United States.
Sheila I MillerEli Lilly and Company, Indianapolis, IN, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Serotonin syndrome (SS) symptoms overlap with adverse events associated with lasmiditan, a 5-HT (serotonin) Methods: Results of eight phase 2 and phase 3 lasmiditan trials ( Results: Of 6,004 lasmiditan-treated clinical trial patients, 15 reported ≥1 treatment-emergent adverse event consistent with signs and symptom(s) of SS. After review, one case met Sternbach and Hunter criteria, two cases potentially met Sternbach criteria, and three cases reported as SS had limited/no information to determine if either criterion was met. During post-marketing surveillance (approximately 13,400 lasmiditan prescriptions), 17 cases with symptom complexes consistent with SS were reported; 3/17 cases had adequate case descriptions to apply predefined criteria. Of these, two met Sternbach and Hunter criteria, and one met Sternbach criteria. Conclusion: Awareness of clinical symptomatology and diagnostic criteria of SS can help clinicians with recognition of rare instances of SS that may occur with lasmiditan. Clinical trial registration: NCT03670810, NCT00384774, NCT00883051, NCT02565186.

Indexed as

5-hydroxytryptamine-1Fdrug interactionlasmiditanmigraineserotonin syndrome

Identifiers

PMID37965170
PMCPMC10641788

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.