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
Escribá, Pablo V. (Universitat de les Illes Balears)
Gil-Agudo, Ángel M. (Hospital Nacional de Parapléjicos (Toledo))
Vidal, Joan (Institut Germans Trias i Pujol. Institut Guttmann)
Sánchez-Raya, Judith (Hospital Universitari Vall d'Hebron)
Salvador-de la Barrera, Sebastián (Complejo Hospitalario Universitario de A Coruña)
Soto-León, Vanesa (Hospital Nacional de Parapléjicos (Toledo))
León-Álvarez, Natacha (Hospital Los Madroños (Brunete, Madrid))
Méndez Ferrer, Bosco (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Membrilla-Mesa, Miguel David (Hospital Universitario Virgen de las Nieves (Granada))
Redondo Galán, Carolina (Hospital Nacional de Parapléjicos (Toledo))
Benito-Penalva, Jesús (Institut Germans Trias i Pujol. Institut Guttmann)
Montoto-Marqués, Antonio (Complejo Hospitalario Universitario de A Coruña)
Medel Rebollo, Javier (Hospital Universitari Vall d'Hebron)
Palazón García, Ramiro (Hospital Nacional de Parapléjicos (Toledo))
Gutiérrez Henares, Francisco (Hospital Nacional de Parapléjicos (Toledo))
Miralles, Marc (Universitat de les Illes Balears)
Torres, Manuel (Universitat de les Illes Balears)
Nieto-Librero, Ana B. (Instituto de Investigación Biomédica de Salamanca)
García Marco, David (Hospital Nacional de Parapléjicos (Toledo))
Gómez, Carmela (Neurofixpharma (Salamanca, Castella i Lleó))
Jimeno, David (Neurofixpharma (Salamanca, Castella i Lleó))
Oliviero, Antonio (Hospital Los Madroños (Brunete, Madrid))

Fecha:	2024
Resumen:	Double-blind, randomized, placebo-controlled, parallel-group multicentric phase IIA clinical trial. To 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. A total of 7 spinal cord injury rehabilitation units in Spain. A 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. No 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. NFX88 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.
Ayudas:	Agencia Estatal de Investigación RTC2019-007399
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Pain management ; Quality of life
Publicado en:	Spinal Cord, Vol. 62 (june 2024) , p. 454-467, ISSN 1476-5624

DOI: 10.1038/s41393-024-01006-4
PMID: 38898145

14 p, 3.0 MB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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