2 results on '"F. Marcaillou"'
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2. Efficacy and safety of a T-type calcium channel blocker in patients with neuropathic pain: A proof-of-concept, randomized, double-blind and controlled trial
- Author
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Christian Lucas, Claude Dubray, Noémie Delage, Christelle Créac’h, G. Mick, M. Letellier, E. Serra, Damien Richard, Pascale Picard, A. Hamdani, Alain Eschalier, S. Soriot‐Thomas, P. Arcagni, Pascale Vergne-Salle, V. Martinez, Michel Lantéri-Minet, D. Delbrouck, E. Bozzolo, C. Maindet, C. Dualé, Christian Gov, H. Alchaar, Nicolas Kerckhove, Bruno Pereira, D. Lefebvre‐Kuntz, Céline Lambert, S. Romettino, L. Balp, N. Leroux‐Bromberg, E. Piquet, C. Brosse, Christophe Mallet, Lise Bernard, F. Marcaillou, Y. Perier, V.S. Hieng, B. Lietar, R. Deleens, M. Navez, D. Gillet, E. Kuhn, Centre de Sciences Nucléaires et de Sciences de la Matière (CSNSM), Université Paris-Sud - Paris 11 (UP11)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Centre National de la Recherche Scientifique (CNRS), CHU Amiens-Picardie, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Centre de Recherche & Innovation Gaz et Energies Nouvelles - GDF Suez (CRIGEN), Gaz de France Suez (GDF Suez), Institut de recherche sur la biologie de l'insecte UMR7261 (IRBI), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), Advanced Technologies R&D, STMicroelectronics, Qualité des eaux et prévention des pollutions (UR QELY), Centre national du machinisme agricole, du génie rural, des eaux et forêts (CEMAGREF), Space Science and Astrobiology Division at Ames, NASA Ames Research Center (ARC), Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service de Pharmacologie Médicale [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre d’Investigation Clinique (CIC), Université de Tours-Centre National de la Recherche Scientifique (CNRS), Neuro-Dol - Clermont Auvergne (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Bureau International des Poids et Mesures (BIPM), Centre de Recherche sur la Matière Divisée (CRMD), Université d'Orléans (UO)-Centre National de la Recherche Scientifique (CNRS), Department of Chemistry and Institute for Nanoscale Physics and chemistry (INPAC), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), Département d'Ingenierie et d'Etudes des Protéines, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Erosion torrentielle neige et avalanches (UR ETGR (ETNA)), Institut national de recherche en sciences et technologies pour l'environnement et l'agriculture (IRSTEA), Méthodes d'Analyses pour le Traitement d'Images et la Stéréorestitution (MATIS), Laboratoire des Sciences et Technologies de l'Information Géographique (LaSTIG), École nationale des sciences géographiques (ENSG), Institut National de l'Information Géographique et Forestière [IGN] (IGN)-Institut National de l'Information Géographique et Forestière [IGN] (IGN)-École nationale des sciences géographiques (ENSG), Institut National de l'Information Géographique et Forestière [IGN] (IGN)-Institut National de l'Information Géographique et Forestière [IGN] (IGN), Institut National d'Horticulture, CHU Gabriel Montpied (CHU), CHU Clermont-Ferrand, CIC Clermont Ferrand, Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Pharmacologie Clinique-CHU Gabriel-Montpied, Université d'Auvergne - Clermont-Ferrand I (UdA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Chimie de Clermont-Ferrand - Clermont Auvergne (ICCF), Sigma CLERMONT (Sigma CLERMONT)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Service de Pharmacologie Médicale [Clermont-Ferrand], and Département d'Ingenierie et d'Etudes des Protéines (DIEP)
- Subjects
Adult ,Male ,0301 basic medicine ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,Population ,Analgesic ,Proof of Concept Study ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,[SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication ,Randomized controlled trial ,law ,medicine ,Humans ,education ,Adverse effect ,ComputingMilieux_MISCELLANEOUS ,Aged ,Analgesics ,education.field_of_study ,business.industry ,Chronic pain ,Middle Aged ,Calcium Channel Blockers ,medicine.disease ,Interim analysis ,3. Good health ,030104 developmental biology ,Anesthesiology and Pain Medicine ,Anticonvulsant ,Anesthesia ,Neuropathic pain ,[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Ethosuximide ,Neuralgia ,Anticonvulsants ,Female ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Chronic Pain ,business ,030217 neurology & neurosurgery - Abstract
Background T‐type calcium channels have been shown to play an important role in the initiation and maintenance of neuropathic pain and represent a promising therapeutic target for new analgesic treatments. Ethosuximide (ETX), an anticonvulsant and a T‐type channel blocker has shown analgesic effect in several chronic pain models but has not yet been evaluated in patients with neuropathic pain. Methods This proof‐of‐concept, multicentre, double‐blind, controlled and randomized trial compared the efficacy and safety of ETX (given as add‐on therapy) to an inactive control (IC) in 114 patients with non‐diabetic peripheral neuropathic pain. After a 7‐day run‐in period, eligible patients aged over 18 years were randomly assigned (1:1) to ETX or IC for 6 weeks. The primary outcome was the difference between groups in the pain intensity (% of change from the baseline to end of treatment) assessed in the intention‐to‐treat population. This study is registered with EudraCT (2013‐004801‐26) and ClinicalTrials.gov (NCT02100046). Results The study was stopped during the interim analysis due to the high number of adverse events in the active treatment group. ETX failed to reduce total pain and showed a poor tolerance in comparison to IC. In the per‐protocol analysis, ETX significantly reduced pain intensity by 15.6% (95% CI −25.8; −5.4) from baseline compared to IC (−7.8%, 95% CI −14.3; −1.3; p = 0.033), but this result must be interpreted with caution because of a small subgroup of patients. Conclusion Ethosuximide did not reduce the severity of neuropathic pain and induces, at the doses used, many adverse events. Significance This article shows that ETX is not effective to treat neuropathic pain. Nevertheless, per‐protocol analysis suggests a possible analgesic effect of ETX. Thus, our work adds significant knowledge to preclinical and clinical data on the benefits of T‐type calcium channel inhibition for the treatment of neuropathic pain.
- Published
- 2018
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