A meta-analysis of randomized double-blind clinical trials in CMT1A to assess the change from baseline in CMTNS and ONLS scales after one year of treatment.
Identifieur interne : 002B78 ( PubMed/Curation ); précédent : 002B77; suivant : 002B79A meta-analysis of randomized double-blind clinical trials in CMT1A to assess the change from baseline in CMTNS and ONLS scales after one year of treatment.
Auteurs : Jonas Mandel [France] ; Viviane Bertrand [France] ; Philippe Lehert [Australie] ; Shahram Attarian [France] ; Laurent Magy [France] ; Joëlle Micallef [France] ; Ilya Chumakov [France] ; Catherine Scart-Grès [France] ; Mickael Guedj [France] ; Daniel Cohen [France]Source :
- Orphanet journal of rare diseases [ 1750-1172 ] ; 2015.
Descripteurs français
- KwdFr :
- MESH :
- traitement médicamenteux : Maladie de Charcot-Marie-Tooth.
- usage thérapeutique : Acide ascorbique, Antioxydants.
- Essais contrôlés randomisés comme sujet, Humains.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Antioxidants, Ascorbic Acid.
- drug therapy : Charcot-Marie-Tooth Disease.
- Humans, Randomized Controlled Trials as Topic.
Abstract
CMT1A is the most common inherited peripheral neuropathy. There is currently no approved treatment. We performed a meta-analysis including four randomized, double-blind, Placebo-controlled clinical trials to assess the disease progression after one year under Placebo, Ascorbic Acid (AA) or PXT3003, a combination of three repurposed drugs. We observed a weak deterioration in patients under Placebo, well below the reported natural disease progression. Patients treated with AA were stable after one year but not significantly different from Placebo. Patients undergoing PXT3003 treatment showed an improvement in CMTNS and ONLS, statistically significant versus Placebo and potentially precursory of a meaningful change in the disease course.
DOI: 10.1186/s13023-015-0293-y
PubMed: 26070802
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wicri:level="1"><nlm:affiliation>Pharnext SAS, Issy-les-Moulineaux, France. viviane.bertrand@pharnext.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharnext SAS, Issy-les-Moulineaux</wicri:regionArea></affiliation></author><author><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine, University of Melbourne, Melbourne, Australia. philippe.lehert@gmail.com.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Medicine, University of Melbourne, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="Attarian, Shahram" sort="Attarian, Shahram" uniqKey="Attarian S" first="Shahram" last="Attarian">Shahram Attarian</name><affiliation wicri:level="1"><nlm:affiliation>Centre de référence des maladies neuromusculaires et de la SLA, Pôle des neurosciences Cliniques, AP-HM et Aix Marseille Université, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre de référence des maladies neuromusculaires et de la SLA, Pôle des neurosciences Cliniques, AP-HM et Aix Marseille Université, Marseille</wicri:regionArea></affiliation></author><author><name sortKey="Magy, Laurent" sort="Magy, Laurent" uniqKey="Magy L" first="Laurent" last="Magy">Laurent Magy</name><affiliation wicri:level="1"><nlm:affiliation>CHU de Limoges Hôpital Dupuytren, Limoges, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>CHU de Limoges Hôpital Dupuytren, Limoges</wicri:regionArea></affiliation></author><author><name sortKey="Micallef, Joelle" sort="Micallef, Joelle" uniqKey="Micallef J" first="Joëlle" last="Micallef">Joëlle Micallef</name><affiliation wicri:level="1"><nlm:affiliation>CIC-Centre de Pharmacologie Clinique et D'Evaluations Thérapeutiques, AP-HM et Aix Marseille Université, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>CIC-Centre de Pharmacologie Clinique et D'Evaluations Thérapeutiques, AP-HM et Aix Marseille Université, Marseille</wicri:regionArea></affiliation></author><author><name sortKey="Chumakov, Ilya" sort="Chumakov, Ilya" uniqKey="Chumakov I" first="Ilya" last="Chumakov">Ilya Chumakov</name><affiliation wicri:level="1"><nlm:affiliation>Pharnext SAS, Issy-les-Moulineaux, France. ilya.chumakov@pharnext.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharnext SAS, Issy-les-Moulineaux</wicri:regionArea></affiliation></author><author><name sortKey="Scart Gres, Catherine" sort="Scart Gres, Catherine" uniqKey="Scart Gres C" first="Catherine" last="Scart-Grès">Catherine Scart-Grès</name><affiliation wicri:level="1"><nlm:affiliation>Pharnext SAS, Issy-les-Moulineaux, France. catherine.scart-gres@pharnext.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharnext SAS, Issy-les-Moulineaux</wicri:regionArea></affiliation></author><author><name sortKey="Guedj, Mickael" sort="Guedj, Mickael" uniqKey="Guedj M" first="Mickael" last="Guedj">Mickael Guedj</name><affiliation wicri:level="1"><nlm:affiliation>Pharnext SAS, Issy-les-Moulineaux, France. mickael.guedj@pharnext.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharnext SAS, Issy-les-Moulineaux</wicri:regionArea></affiliation></author><author><name sortKey="Cohen, Daniel" sort="Cohen, Daniel" uniqKey="Cohen D" first="Daniel" last="Cohen">Daniel Cohen</name><affiliation wicri:level="1"><nlm:affiliation>Pharnext SAS, Issy-les-Moulineaux, France. jmandel@pharnext.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharnext SAS, Issy-les-Moulineaux</wicri:regionArea></affiliation></author></analytic><series><title level="j">Orphanet journal of rare diseases</title><idno type="eISSN">1750-1172</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antioxidants (therapeutic use)</term><term>Ascorbic Acid (therapeutic use)</term><term>Charcot-Marie-Tooth Disease (drug therapy)</term><term>Humans</term><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Acide ascorbique (usage thérapeutique)</term><term>Antioxydants (usage thérapeutique)</term><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term><term>Maladie de Charcot-Marie-Tooth (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antioxidants</term><term>Ascorbic Acid</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Charcot-Marie-Tooth Disease</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Maladie de Charcot-Marie-Tooth</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Acide ascorbique</term><term>Antioxydants</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">CMT1A is the most common inherited peripheral neuropathy. There is currently no approved treatment. We performed a meta-analysis including four randomized, double-blind, Placebo-controlled clinical trials to assess the disease progression after one year under Placebo, Ascorbic Acid (AA) or PXT3003, a combination of three repurposed drugs. We observed a weak deterioration in patients under Placebo, well below the reported natural disease progression. Patients treated with AA were stable after one year but not significantly different from Placebo. Patients undergoing PXT3003 treatment showed an improvement in CMTNS and ONLS, statistically significant versus Placebo and potentially precursory of a meaningful change in the disease course.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26070802</PMID><DateCreated><Year>2015</Year><Month>06</Month><Day>26</Day></DateCreated><DateCompleted><Year>2016</Year><Month>02</Month><Day>29</Day></DateCompleted><DateRevised><Year>2015</Year><Month>06</Month><Day>27</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1750-1172</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><PubDate><Year>2015</Year><Month>Jun</Month><Day>13</Day></PubDate></JournalIssue><Title>Orphanet journal of rare diseases</Title><ISOAbbreviation>Orphanet J Rare Dis</ISOAbbreviation></Journal><ArticleTitle>A meta-analysis of randomized double-blind clinical trials in CMT1A to assess the change from baseline in CMTNS and ONLS scales after one year of treatment.</ArticleTitle><Pagination><MedlinePgn>74</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13023-015-0293-y</ELocationID><Abstract><AbstractText>CMT1A is the most common inherited peripheral neuropathy. There is currently no approved treatment. We performed a meta-analysis including four randomized, double-blind, Placebo-controlled clinical trials to assess the disease progression after one year under Placebo, Ascorbic Acid (AA) or PXT3003, a combination of three repurposed drugs. We observed a weak deterioration in patients under Placebo, well below the reported natural disease progression. Patients treated with AA were stable after one year but not significantly different from Placebo. Patients undergoing PXT3003 treatment showed an improvement in CMTNS and ONLS, statistically significant versus Placebo and potentially precursory of a meaningful change in the disease course.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mandel</LastName><ForeName>Jonas</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Pharnext SAS, Issy-les-Moulineaux, France. jmandel@pharnext.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bertrand</LastName><ForeName>Viviane</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Pharnext SAS, Issy-les-Moulineaux, France. viviane.bertrand@pharnext.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lehert</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Faculty of Medicine, University of Melbourne, Melbourne, Australia. philippe.lehert@gmail.com.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculty of Economics, UCL Mons, Louvain, Belgium. philippe.lehert@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Attarian</LastName><ForeName>Shahram</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Centre de référence des maladies neuromusculaires et de la SLA, Pôle des neurosciences Cliniques, AP-HM et Aix Marseille Université, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Magy</LastName><ForeName>Laurent</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>CHU de Limoges Hôpital Dupuytren, Limoges, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Micallef</LastName><ForeName>Joëlle</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>CIC-Centre de Pharmacologie Clinique et D'Evaluations Thérapeutiques, AP-HM et Aix Marseille Université, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chumakov</LastName><ForeName>Ilya</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Pharnext SAS, Issy-les-Moulineaux, France. ilya.chumakov@pharnext.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scart-Grès</LastName><ForeName>Catherine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Pharnext SAS, Issy-les-Moulineaux, France. catherine.scart-gres@pharnext.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guedj</LastName><ForeName>Mickael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Pharnext SAS, Issy-les-Moulineaux, France. mickael.guedj@pharnext.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cohen</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Pharnext SAS, Issy-les-Moulineaux, France. jmandel@pharnext.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016422">Letter</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>06</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Orphanet J Rare Dis</MedlineTA><NlmUniqueID>101266602</NlmUniqueID><ISSNLinking>1750-1172</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000975">Antioxidants</NameOfSubstance></Chemical><Chemical><RegistryNumber>PQ6CK8PD0R</RegistryNumber><NameOfSubstance UI="D001205">Ascorbic Acid</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Nat Med. 2004 Apr;10(4):396-401</RefSource><PMID 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RefType="Cites"><RefSource>J Peripher Nerv Syst. 2014 Sep;19(3):192-6</RefSource><PMID Version="1">25400013</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Neuromuscul Disord. 2014 Nov;24(11):1003-17</RefSource><PMID Version="1">25085517</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000975" MajorTopicYN="N">Antioxidants</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001205" MajorTopicYN="N">Ascorbic Acid</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002607" MajorTopicYN="N">Charcot-Marie-Tooth Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" 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