Evidence map›Paper›PMID 34742230›Full record

Trial reportThe journal of headache and pain2021

Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine.

C Tassorelli, S Bragg, J H Krege, E G Doty, P A Ardayfio, D Ruff, S A Dowsett, T Schwedt

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03670810 (Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. The 5-HTNature reviews. Neurology · 2023
    Review
  9. Review
  10. Ditans: a new prospective for the therapy of migraine attack?Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Review
  11. 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.

C TassorelliUniversity of Pavia, Pavia, Lombardy, Italy.
S BraggEli Lilly and Company, IN, 46285, Indianapolis, USA. bragg_sonja_m@lilly.com.
J H KregeEli Lilly and Company, IN, 46285, Indianapolis, USA.
E G DotyEli Lilly and Company, IN, 46285, Indianapolis, USA.
P A ArdayfioEli Lilly and Company, IN, 46285, Indianapolis, USA.
D RuffEli Lilly and Company, IN, 46285, Indianapolis, USA.
S A DowsettEli Lilly and Company, IN, 46285, Indianapolis, USA.
T SchwedtMayo Clinic, Phoenix, AZ, USA.

Funding

Eli Lilly and Company Study sponsored by Eli Lilly and Company
6 · The paper itself

Abstract

backgroundLasmiditan (LTN) is a selective 5-HT

methodsPatients were randomized 1:1:1 to LTN 200 mg (LTN200), LTN100, or a control group that received placebo for 3 attacks and LTN50 for either the 3rd or 4th attack (1:1). Safety analyses were conducted for patients who took ≥1 dose of study drug and, in some cases, those who took all 4 doses.

resultsOverall, 1471 patients treated 4494 attacks. The incidences of treatment-emergent serious adverse events (SAEs) were - placebo, n=2 (0.4 %); LTN100, n=1 (0.2 %); LTN200, n=2 (0.4 %); no specific treatment-emergent SAE was reported in more than one patient. The most common treatment emergent adverse events (TEAEs) with lasmiditan were dizziness, paresthesia, fatigue, nausea, vertigo, and somnolence; the vast majority were mild or moderate in severity. The incidences of these TEAEs were highest during the first attack and decreased during subsequent attacks. For patients who experienced a common TEAE with the first attack, less than 45 % experienced the same event in subsequent attacks. Patients who did not experience an event in the 1st attack infrequently experienced the same event in subsequent attacks. The time of onset of the common TEAE ranged from ~40 min to 1 h (dependent upon TEAE) and, for individual TEAE, the onset was similar across attacks. Duration was dependent upon TEAE and attack. It was shortest for paresthesia (< 2 h for all attacks); it ranged from 1.8 to 5.5 h for other common TEAEs and was generally similar across attacks. Serotonin syndrome was reported for 2 patients post LTN dosing; there were no meaningful differences across treatment groups in suicidality; there was no evidence of an increase in motor vehicle accidents.

conclusionIn this blinded, controlled, multiple-attack study, LTN was associated with generally mild or moderate CNS-related TEAEs of short duration. TEAEs tended to decrease in frequency across the 4 attacks.

trial registrationNCT03670810.

Indexed as

Migraine DisordersSerotonin Receptor AgonistsAdultBenzamidesDouble-Blind MethodHumansPiperidinesPyridinesTreatment OutcomeBenzamideslasmiditanPiperidinesPyridinesSerotonin Receptor AgonistsAdverse eventsClinical trialConsistencyLasmiditanMigraineMultiple attacksSafety

Identifiers

PMID34742230
PMCPMC8572440

What OpenQuestion holds

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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.