NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.
Identifieur interne : 000044 ( PubMed/Corpus ); précédent : 000043; suivant : 000045NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.
Auteurs : Christopher F. O'Brien ; Roland Jimenez ; Robert A. Hauser ; Stewart A. Factor ; Joshua Burke ; Daniel Mandri ; Julio C. Castro-GayolSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2015.
Abstract
Tardive dyskinesia is a persistent movement disorder induced by chronic neuroleptic exposure. NBI-98854 is a novel, highly selective, vesicular monoamine transporter 2 inhibitor. We present results of a randomized, 6-week, double-blind, placebo-controlled, dose-titration study evaluating the safety, tolerability, and efficacy of NBI-98854 for the treatment of tardive dyskinesia.
DOI: 10.1002/mds.26330
PubMed: 26346941
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.</title><author><name sortKey="O Brien, Christopher F" sort="O Brien, Christopher F" uniqKey="O Brien C" first="Christopher F" last="O'Brien">Christopher F. O'Brien</name><affiliation><nlm:affiliation>Neurocrine Biosciences, San Diego, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jimenez, Roland" sort="Jimenez, Roland" uniqKey="Jimenez R" first="Roland" last="Jimenez">Roland Jimenez</name><affiliation><nlm:affiliation>Neurocrine Biosciences, San Diego, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation><nlm:affiliation>University of South Florida, Tampa, Florida, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Factor, Stewart A" sort="Factor, Stewart A" uniqKey="Factor S" first="Stewart A" last="Factor">Stewart A. Factor</name><affiliation><nlm:affiliation>Emory University, Atlanta, Georgia, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Burke, Joshua" sort="Burke, Joshua" uniqKey="Burke J" first="Joshua" last="Burke">Joshua Burke</name><affiliation><nlm:affiliation>Neurocrine Biosciences, San Diego, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mandri, Daniel" sort="Mandri, Daniel" uniqKey="Mandri D" first="Daniel" last="Mandri">Daniel Mandri</name><affiliation><nlm:affiliation>Biscayne Bay Institute, Miami, Florida, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Castro Gayol, Julio C" sort="Castro Gayol, Julio C" uniqKey="Castro Gayol J" first="Julio C" last="Castro-Gayol">Julio C. Castro-Gayol</name><affiliation><nlm:affiliation>Research in Miami, Miami, Florida, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26346941</idno><idno type="pmid">26346941</idno><idno type="doi">10.1002/mds.26330</idno><idno type="wicri:Area/PubMed/Corpus">000044</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.</title><author><name sortKey="O Brien, Christopher F" sort="O Brien, Christopher F" uniqKey="O Brien C" first="Christopher F" last="O'Brien">Christopher F. O'Brien</name><affiliation><nlm:affiliation>Neurocrine Biosciences, San Diego, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jimenez, Roland" sort="Jimenez, Roland" uniqKey="Jimenez R" first="Roland" last="Jimenez">Roland Jimenez</name><affiliation><nlm:affiliation>Neurocrine Biosciences, San Diego, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation><nlm:affiliation>University of South Florida, Tampa, Florida, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Factor, Stewart A" sort="Factor, Stewart A" uniqKey="Factor S" first="Stewart A" last="Factor">Stewart A. Factor</name><affiliation><nlm:affiliation>Emory University, Atlanta, Georgia, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Burke, Joshua" sort="Burke, Joshua" uniqKey="Burke J" first="Joshua" last="Burke">Joshua Burke</name><affiliation><nlm:affiliation>Neurocrine Biosciences, San Diego, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mandri, Daniel" sort="Mandri, Daniel" uniqKey="Mandri D" first="Daniel" last="Mandri">Daniel Mandri</name><affiliation><nlm:affiliation>Biscayne Bay Institute, Miami, Florida, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Castro Gayol, Julio C" sort="Castro Gayol, Julio C" uniqKey="Castro Gayol J" first="Julio C" last="Castro-Gayol">Julio C. Castro-Gayol</name><affiliation><nlm:affiliation>Research in Miami, Miami, Florida, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Tardive dyskinesia is a persistent movement disorder induced by chronic neuroleptic exposure. NBI-98854 is a novel, highly selective, vesicular monoamine transporter 2 inhibitor. We present results of a randomized, 6-week, double-blind, placebo-controlled, dose-titration study evaluating the safety, tolerability, and efficacy of NBI-98854 for the treatment of tardive dyskinesia.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="In-Data-Review"><PMID Version="1">26346941</PMID><DateCreated><Year>2015</Year><Month>10</Month><Day>17</Day></DateCreated><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>30</Volume><Issue>12</Issue><PubDate><Year>2015</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.</ArticleTitle><Pagination><MedlinePgn>1681-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.26330</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Tardive dyskinesia is a persistent movement disorder induced by chronic neuroleptic exposure. NBI-98854 is a novel, highly selective, vesicular monoamine transporter 2 inhibitor. We present results of a randomized, 6-week, double-blind, placebo-controlled, dose-titration study evaluating the safety, tolerability, and efficacy of NBI-98854 for the treatment of tardive dyskinesia.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Male and female adult subjects with moderate or severe tardive dyskinesia were included. NBI-98854 or placebo was given once per day starting at 25 mg and then escalated by 25 mg to a maximum of 75 mg based on dyskinesia and tolerability assessment. The primary efficacy endpoint was the change in Abnormal Involuntary Movement Scale from baseline at week 6 scored by blinded, central video raters. The secondary endpoint was the Clinical Global Impression of Change-Tardive Dyskinesia score assessed by the blinded investigator.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Two hundred five potential subjects were screened, and 102 were randomized; 76% of NBI-98854 subjects and 80% of placebo subjects reached the maximum allowed dose. Abnormal Involuntary Movement Scale scores for NBI-98854 compared with placebo were significantly reduced (p = 0.0005). Active drug was also superior on the Clinical Global Impression of Change-Tardive Dyskinesia (p < 0.0001). Treatment-emergent adverse event rates were 49% in the NBI-98854 and 33% in the placebo subjects. The most common adverse events (active vs. placebo) were fatigue and headache (9.8% vs. 4.1%) and constipation and urinary tract infection (3.9% vs. 6.1%). No clinically relevant changes in safety assessments were noted.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">NBI-98854 significantly improved tardive dyskinesia and was well tolerated in patients. These results support the phase 3 clinical trials of NBI-98854 now underway. © 2015 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</AbstractText><CopyrightInformation>© 2015 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>O'Brien</LastName><ForeName>Christopher F</ForeName><Initials>CF</Initials><AffiliationInfo><Affiliation>Neurocrine Biosciences, San Diego, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jimenez</LastName><ForeName>Roland</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Neurocrine Biosciences, San Diego, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>University of South Florida, Tampa, Florida, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Factor</LastName><ForeName>Stewart A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>Emory University, Atlanta, Georgia, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Burke</LastName><ForeName>Joshua</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Neurocrine Biosciences, San Diego, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mandri</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Biscayne Bay Institute, Miami, Florida, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Castro-Gayol</LastName><ForeName>Julio C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Research in Miami, Miami, Florida, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>09</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">antipsychotic drugs</Keyword><Keyword MajorTopicYN="N">randomized controlled trial</Keyword><Keyword MajorTopicYN="N">tardive dyskinesia</Keyword><Keyword MajorTopicYN="N">vesicular monoamine transporter (VMAT2)</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>3</Month><Day>4</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>6</Month><Day>8</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>6</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2015</Year><Month>9</Month><Day>8</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26346941</ArticleId><ArticleId IdType="doi">10.1002/mds.26330</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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