Your browser doesn't support javascript.
loading
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; Gil-Agudo, Ángel M; Vidal Samsó, Joan; Sánchez-Raya, Judith; Salvador-de la Barrera, Sebastián; Soto-León, Vanesa; León-Álvarez, Natacha; Méndez Ferrer, Bosco; Membrilla-Mesa, Miguel David; Redondo Galán, Carolina; Benito-Penalva, Jesús; Montoto-Marqués, Antonio; Medel Rebollo, Javier; Palazón García, Ramiro; Gutiérrez Henares, Francisco; Miralles, Marc; Torres, Manuel; Nieto-Librero, Ana B; García Marco, David; Gómez, Carmela; Jimeno, David; Oliviero, Antonio.
Afiliación
  • Escribá PV; Universidad Islas Baleares, Palma, Islas Baleares, Spain.
  • Gil-Agudo ÁM; Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Vidal Samsó J; Fundación Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la Universitat Autònoma de Barcelona, 08916, Badalona, Spain.
  • Sánchez-Raya J; Hospital Campus Vall d'Hebron, Barcelona, Spain.
  • Salvador-de la Barrera S; Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • Soto-León V; Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • León-Álvarez N; Hospital Los Madroños, Brunete, Madrid, Spain.
  • Méndez Ferrer B; Hospital Universitario Virgen del Rocio, Sevilla, Spain.
  • Membrilla-Mesa MD; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
  • Redondo Galán C; Hospital Universitario Virgen de las Nieves, Granada, Spain.
  • Benito-Penalva J; Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Montoto-Marqués A; Fundación Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la Universitat Autònoma de Barcelona, 08916, Badalona, Spain.
  • Medel Rebollo J; Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • Palazón García R; Hospital Campus Vall d'Hebron, Barcelona, Spain.
  • Gutiérrez Henares F; Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Miralles M; Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Torres M; Universidad Islas Baleares, Palma, Islas Baleares, Spain.
  • Nieto-Librero AB; Universidad Islas Baleares, Palma, Islas Baleares, Spain.
  • García Marco D; Departamento de Estadística, Universidad de Salamanca, Salamanca, Spain.
  • Gómez C; Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain.
  • Jimeno D; Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Oliviero A; Neurofixpharma SA, Salamanca, Spain.
Spinal Cord ; 62(8): 454-467, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38898145
ABSTRACT
STUDY

DESIGN:

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

OBJECTIVE:

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.

SETTING:

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

METHODS:

A total of 61 adult with traumatic complete or incomplete spinal cord injury (C4-T12 level), were randomised 1111 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.

RESULTS:

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.

CONCLUSIONS:

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.
Asunto(s)
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Neuralgia Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Spinal Cord Asunto de la revista: NEUROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Neuralgia Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Spinal Cord Asunto de la revista: NEUROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido