Evidence map›Paper›PMID 32669869›Full record

ArticleJournal of pain research2020

Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia.

Mona Kotecha, William P Cheshire, Helen Finnigan, Kathryn Giblin, Himanshu Naik, Joanne Palmer, Simon Tate, Joanna M Zakrzewska

2 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pain research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

NCT03070132 phase3withdrawnnot on this mapstarted 2023, after this paper: background citation

A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia

TypeinterventionalSponsorBiogenRan2023 to 2026Enrolled0ConditionsTrigeminal NeuralgiaArmsBIIB074, Placebo
NCT03637387 phase3withdrawnnot on this mapstarted 2023, after this paper: background citation

A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia

TypeinterventionalSponsorBiogenRan2023 to 2026Enrolled0ConditionsTrigeminal NeuralgiaArmsBIIB074, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 26 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Review
  6. Identification and targeting of a unique NaProceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  7. Review
  8. Neuropathic pain; what we know and what we should do about it.Frontiers in pain research (Lausanne, Switzerland) · 2023
    Review
  9. Inhibition of NaRSC medicinal chemistry · 2022
    Review
  10. 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 at 4 institutions in 2 countries.

Mona KotechaBiogen, Cambridge, MA, USA.
William P CheshireDepartment of Neurology, Mayo Clinic Florida, Jacksonville, FL, USA.ORCID 0000-0002-6364-5362
Helen FinniganBiogen, Maidenhead, UK.
Kathryn GiblinBiogen, Cambridge, MA, USA.
Himanshu NaikBiogen, Cambridge, MA, USA.
Joanne PalmerConvergence Pharmaceuticals, a Biogen Company, Cambridge, UK.
Simon TateConvergence Pharmaceuticals, a Biogen Company, Cambridge, UK.
Joanna M ZakrzewskaFacial Pain Unit and Pain Management Centre, University College London Hospitals NHS Foundation Trust/University College London, London, UK.ORCID 0000-0001-7805-5851
Biogen (United Kingdom) · GBBiogen (United States) · USMayo Clinic in Florida · USUniversity College London Hospitals NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeVixotrigine (BIIB074) is a voltage- and use-dependent sodium channel blocker. These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs. PATIENTS AND

methodsTwo double-blind randomized withdrawal studies are planned to evaluate the efficacy and safety of vixotrigine compared with placebo in participants with TN (NCT03070132 and NCT03637387). Participant criteria include ≥18 years old who have classical, purely paroxysmal TN diagnosed ≥3 months prior to study entry, who experience ≥3 paroxysms of pain/day. The two studies will include a screening period, 7-day run-in period, a 4- or 6-week single-dose-blind dose-optimization period (Study 1) or 4-week open-label period (Study 2), and 14-week double-blind period. Participants will receive vixotrigine 150 mg orally three times daily in the dose-optimization and open-label periods. The primary endpoint of both studies is the proportion of participants classified as responders at Week 12 of the double-blind period. Secondary endpoints include safety measures, quality of life, and evaluation of vixotrigine population pharmacokinetics.

conclusionThere is a need for an effective, well-tolerated, noninvasive treatment for the neuropathic pain associated with TN. The proposed studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with TN.

Indexed as

EERWenriched enrollment randomized withdrawalfacial painneuropathic painPenn Facial Pain Scale-RevisedPENN-FPS-Rvoltage-gated sodium channels

Identifiers

PMID32669869
PMCPMC7335847
OpenAlexW3040136171

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.