Evidence map›Paper›PMID 33278330›Full record

Trial reportClinical and translational science2021

Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of Vixotrigine in Healthy Volunteers.

Himanshu Naik, Deb J Steiner, Mark Versavel, Joanne Palmer, Regan Fong

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 35% of its field
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

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

  1. Pooled it
  2. Review
  3. Article
  4. Targeting NaInternational journal of molecular sciences · 2026
    Review
  5. Article
  6. 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

5 authors at 3 institutions in 2 countries.

Himanshu NaikBiogen, Cambridge, Massachusetts, USA.
Deb J SteinerBiogen, Cambridge, Massachusetts, USA.
Mark VersavelBiogen, Cambridge, Massachusetts, USA.
Joanne PalmerGlaxoSmithKline, Harlow, UK.
Regan FongGlaxoSmithKline, King of Prussia, Pennsylvania, USA.
Biogen (United States) · USGlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · US

Funding

BiogenGlaxoSmithKline
6 · The paper itself

Abstract

Neuropathic pain affects ~ 6.9-10% of the general population and leads to loss of function, anxiety, depression, sleep disturbance, and impaired cognition. Here, we report the safety, tolerability, and pharmacokinetics of a voltage-dependent and use-dependent sodium channel blocker, vixotrigine, currently under investigation for the treatment of neuropathic pain conditions. The randomized, placebo-controlled, phase I clinical trials were split into single ascending dose (SAD) and multiple ascending dose (MAD) studies. Healthy volunteers received oral vixotrigine as either single doses followed by a ≥ 7-day washout period for up to 5 dosing sessions (SAD, n = 30), or repeat doses (once or twice daily) for 14 and 28 days (MAD, n = 51). Adverse events (AEs), maximum observed vixotrigine plasma concentration (C

Indexed as

Administration, OralAdolescentAdultAgedArea Under CurveDizzinessDose-Response Relationship, DrugDouble-Blind MethodFemaleHalf-LifeHealthy VolunteersHumansMaleMiddle AgedNeuralgiaPhenyl EthersPhenyl EthersProlineSodium Channel Blockersvixotrigine

Identifiers

PMID33278330
PMCPMC8301589
OpenAlexW3111497338

What OpenQuestion holds

Textmetadata
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.