Evidence map›Paper›PMID 38898145›Full record

Trial reportSpinal cord2024

Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury.

Pablo V Escribá, Ángel M Gil-Agudo, Joan Vidal Samsó, Judith Sánchez-Raya, Sebastián Salvador-de la Barrera, Vanesa Soto-León, Natacha León-Álvarez, Bosco Méndez Ferrer, Miguel David Membrilla-Mesa, Carolina Redondo Galán and 12 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Spinal cord, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

22 authors.

Pablo V EscribáUniversidad Islas Baleares, Palma, Islas Baleares, Spain.
Ángel M Gil-AgudoHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.ORCID 0000-0001-5082-4225
Joan Vidal SamsóFundación Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la Universitat Autònoma de Barcelona, 08916, Badalona, Spain.
Judith Sánchez-RayaHospital Campus Vall d'Hebron, Barcelona, Spain.
Sebastián Salvador-de la BarreraComplejo Hospitalario Universitario A Coruña, A Coruña, Spain.ORCID 0000-0002-9810-7548
Vanesa Soto-LeónHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
Natacha León-ÁlvarezHospital Los Madroños, Brunete, Madrid, Spain.
Bosco Méndez FerrerHospital Universitario Virgen del Rocio, Sevilla, Spain.
Miguel David Membrilla-MesaInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
Carolina Redondo GalánHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
Jesús Benito-PenalvaFundación Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la Universitat Autònoma de Barcelona, 08916, Badalona, Spain.
Antonio Montoto-MarquésComplejo Hospitalario Universitario A Coruña, A Coruña, Spain.ORCID 0000-0003-1773-365X
Javier Medel RebolloHospital Campus Vall d'Hebron, Barcelona, Spain.
Ramiro Palazón GarcíaHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
Francisco Gutiérrez HenaresHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
Marc MirallesUniversidad Islas Baleares, Palma, Islas Baleares, Spain.
Manuel TorresUniversidad Islas Baleares, Palma, Islas Baleares, Spain.ORCID 0000-0002-5076-8486
Ana B Nieto-LibreroDepartamento de Estadística, Universidad de Salamanca, Salamanca, Spain.ORCID 0000-0001-6643-247X
David García MarcoHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
Carmela GómezNeurofixpharma SA, Salamanca, Spain.ORCID 0000-0002-9041-886X
David JimenoNeurofixpharma SA, Salamanca, Spain.
Antonio OlivieroHospital Nacional de Parapléjicos, SESCAM, Toledo, Spain. antonioo@sescam.jccm.es.ORCID 0000-0001-7723-0478

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designDouble-blind, randomized, placebo-controlled, parallel-group multicentric phase IIA clinical trial.

objectiveTo assess the safety and tolerability of oral administration of NFX-88 in subjects with chronic spinal cord injury (SCI) and explore its efficacy in pain control.

settingA total of 7 spinal cord injury rehabilitation units in Spain.

methodsA total of 61 adult with traumatic complete or incomplete spinal cord injury (C4-T12 level), were randomised 1:1:1:1 to a placebo, NFX88 1.05 g, 2.1 g, 4.2 g/day for up to 12 weeks. The placebo or NFX-88 was administered as add-on therapy to pre-existing pregabalin (150-300 mg per day). Safety and tolerability were evaluated, and the Visual Analogue Scale (VAS) was the primary measure to explore the efficacy of NFX-88 in pain control.

resultsNo severe treatment-related adverse effects were reported for any of the four study groups. 44 SCI individuals completed the study and were analysed. The data obtained from the VAS analysis and the PainDETECT Questionnaire (PD-Q) suggested that the combination of NFX88 with pregabalin is more effective than pregabalin with placebo at reducing neuropathic pain (NP) in individuals with SCI and that the dose 2.10 g/day causes the most dramatic pain relief.

conclusionsNFX88 treatment was found to be highly safe and well tolerated, with the dose of 2.10 g/day being the most effective at causing pain relief. Thus, the promising efficacy of this first-in-class lipid mediator deserves further consideration in future clinical trials.

Indexed as

NeuralgiaSpinal Cord InjuriesAdministration, OralAdultAgedAnalgesicsDouble-Blind MethodFemaleHumansMaleMiddle AgedPain MeasurementPregabalinTreatment OutcomeYoung AdultAnalgesicsPregabalin

Identifiers

PMID38898145
PMCPMC11300303

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.