A randomized, phase 2 clinical trial of lithium carbonate in Machado-Joseph disease.
Identifieur interne : 000700 ( PubMed/Checkpoint ); précédent : 000699; suivant : 000701A randomized, phase 2 clinical trial of lithium carbonate in Machado-Joseph disease.
Auteurs : Jonas Alex Morales Saute [Brésil] ; Raphael Machado De Castilhos ; Thais Lampert Monte ; Artur Francisco Schumacher-Schuh ; Karina Carvalho Donis ; Rui D'Ávila ; Gabriele Nunes Souza ; Aline Dutra Russo ; Gabriel Vasata Furtado ; Tailise Conte Gheno ; Diogo Onofre Gomes De Souza ; Luis Valmor Cruz Portela ; Maria-Luiza Saraiva-Pereira ; Suzi Alvez Camey ; Vanessa Bielefeld Leotti Torman ; Carlos Roberto De Mello Rieder ; Laura Bannach JardimSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Enzyme Inhibitors, Lithium Carbonate.
- chemical , therapeutic use : Enzyme Inhibitors, Lithium Carbonate.
- drug therapy : Machado-Joseph Disease.
- Adult, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Because lithium exerts neuroprotective effects in preclinical models of polyglutamine disorders, our objective was to assess the safety and efficacy of lithium carbonate (0.5-0.8 milliequivalents per liter) in patients with Machado-Joseph disease (spinocerebellar ataxia type 3 [MJD/SCA3]).
DOI: 10.1002/mds.25803
PubMed: 24399647
Affiliations:
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:24399647Le document en format XML
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<author><name sortKey="De Castilhos, Raphael Machado" sort="De Castilhos, Raphael Machado" uniqKey="De Castilhos R" first="Raphael Machado" last="De Castilhos">Raphael Machado De Castilhos</name>
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<author><name sortKey="Saraiva Pereira, Maria Luiza" sort="Saraiva Pereira, Maria Luiza" uniqKey="Saraiva Pereira M" first="Maria-Luiza" last="Saraiva-Pereira">Maria-Luiza Saraiva-Pereira</name>
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<author><name sortKey="Camey, Suzi Alvez" sort="Camey, Suzi Alvez" uniqKey="Camey S" first="Suzi Alvez" last="Camey">Suzi Alvez Camey</name>
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<author><name sortKey="Torman, Vanessa Bielefeld Leotti" sort="Torman, Vanessa Bielefeld Leotti" uniqKey="Torman V" first="Vanessa Bielefeld Leotti" last="Torman">Vanessa Bielefeld Leotti Torman</name>
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<author><name sortKey="De Mello Rieder, Carlos Roberto" sort="De Mello Rieder, Carlos Roberto" uniqKey="De Mello Rieder C" first="Carlos Roberto" last="De Mello Rieder">Carlos Roberto De Mello Rieder</name>
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<author><name sortKey="Jardim, Laura Bannach" sort="Jardim, Laura Bannach" uniqKey="Jardim L" first="Laura Bannach" last="Jardim">Laura Bannach Jardim</name>
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<term>Enzyme Inhibitors (therapeutic use)</term>
<term>Female</term>
<term>Humans</term>
<term>Lithium Carbonate (adverse effects)</term>
<term>Lithium Carbonate (therapeutic use)</term>
<term>Machado-Joseph Disease (drug therapy)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Treatment Outcome</term>
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<term>Double-Blind Method</term>
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<front><div type="abstract" xml:lang="en">Because lithium exerts neuroprotective effects in preclinical models of polyglutamine disorders, our objective was to assess the safety and efficacy of lithium carbonate (0.5-0.8 milliequivalents per liter) in patients with Machado-Joseph disease (spinocerebellar ataxia type 3 [MJD/SCA3]).</div>
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<DateCreated><Year>2014</Year>
<Month>04</Month>
<Day>04</Day>
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<DateCompleted><Year>2014</Year>
<Month>12</Month>
<Day>03</Day>
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<JournalIssue CitedMedium="Internet"><Volume>29</Volume>
<Issue>4</Issue>
<PubDate><Year>2014</Year>
<Month>Apr</Month>
</PubDate>
</JournalIssue>
<Title>Movement disorders : official journal of the Movement Disorder Society</Title>
<ISOAbbreviation>Mov. Disord.</ISOAbbreviation>
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<ArticleTitle>A randomized, phase 2 clinical trial of lithium carbonate in Machado-Joseph disease.</ArticleTitle>
<Pagination><MedlinePgn>568-73</MedlinePgn>
</Pagination>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Because lithium exerts neuroprotective effects in preclinical models of polyglutamine disorders, our objective was to assess the safety and efficacy of lithium carbonate (0.5-0.8 milliequivalents per liter) in patients with Machado-Joseph disease (spinocerebellar ataxia type 3 [MJD/SCA3]).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">For this phase 2, single-center, double-blind, parallel, placebo-controlled trial (ClinicalTrials.gov identifier NCT01096082), 62 patients who had MJD/SCA3 with a disease duration ≤10 years and an independent gait were randomly assigned (1:1) to receive either lithium or placebo.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">After 24 weeks, 169 adverse events were reported, including 50.3% in the lithium group (P = 1.00; primary safety outcome). Sixty patients (31 in the placebo group and 29 in the lithium group) were analyzed for efficacy (intention-to-treat analysis). Mean progression between groups did not differ according to scores on the Neurological Examination Score for the Assessment of Spinocerebellar Ataxia (NESSCA) after 48 weeks (-0.35; 95% confidence interval, -1.7 to 1.0; primary efficacy outcome). The lithium group exhibited minor progression on the PATA speech-rate (P = 0.002), the nondominant Click Test (P = 0.023), the Spinocerebellar Ataxia Functional Index (P = 0.003), and the Composite Cerebellar Functional Score (P = 0.029).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Lithium was safe and well tolerated, but it had no effect on progression when measured using the NESSCA in patients with MJD/SCA3. This slowdown in secondary outcomes deserves further clarification.</AbstractText>
<CopyrightInformation>© 2014 International Parkinson and Movement Disorder Society.</CopyrightInformation>
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<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Saute</LastName>
<ForeName>Jonas Alex Morales</ForeName>
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<AffiliationInfo><Affiliation>Postgraduate Program in Medical Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil; Medical Genetics, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil.</Affiliation>
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<Author ValidYN="Y"><LastName>de Castilhos</LastName>
<ForeName>Raphael Machado</ForeName>
<Initials>RM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Monte</LastName>
<ForeName>Thais Lampert</ForeName>
<Initials>TL</Initials>
</Author>
<Author ValidYN="Y"><LastName>Schumacher-Schuh</LastName>
<ForeName>Artur Francisco</ForeName>
<Initials>AF</Initials>
</Author>
<Author ValidYN="Y"><LastName>Donis</LastName>
<ForeName>Karina Carvalho</ForeName>
<Initials>KC</Initials>
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<Author ValidYN="Y"><LastName>D'Ávila</LastName>
<ForeName>Rui</ForeName>
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<Author ValidYN="Y"><LastName>Souza</LastName>
<ForeName>Gabriele Nunes</ForeName>
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<Author ValidYN="Y"><LastName>Russo</LastName>
<ForeName>Aline Dutra</ForeName>
<Initials>AD</Initials>
</Author>
<Author ValidYN="Y"><LastName>Furtado</LastName>
<ForeName>Gabriel Vasata</ForeName>
<Initials>GV</Initials>
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<Author ValidYN="Y"><LastName>Gheno</LastName>
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<Author ValidYN="Y"><LastName>de Souza</LastName>
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</Author>
<Author ValidYN="Y"><LastName>Portela</LastName>
<ForeName>Luis Valmor Cruz</ForeName>
<Initials>LV</Initials>
</Author>
<Author ValidYN="Y"><LastName>Saraiva-Pereira</LastName>
<ForeName>Maria-Luiza</ForeName>
<Initials>ML</Initials>
</Author>
<Author ValidYN="Y"><LastName>Camey</LastName>
<ForeName>Suzi Alvez</ForeName>
<Initials>SA</Initials>
</Author>
<Author ValidYN="Y"><LastName>Torman</LastName>
<ForeName>Vanessa Bielefeld Leotti</ForeName>
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<Author ValidYN="Y"><LastName>de Mello Rieder</LastName>
<ForeName>Carlos Roberto</ForeName>
<Initials>CR</Initials>
</Author>
<Author ValidYN="Y"><LastName>Jardim</LastName>
<ForeName>Laura Bannach</ForeName>
<Initials>LB</Initials>
</Author>
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<name sortKey="Portela, Luis Valmor Cruz" sort="Portela, Luis Valmor Cruz" uniqKey="Portela L" first="Luis Valmor Cruz" last="Portela">Luis Valmor Cruz Portela</name>
<name sortKey="Russo, Aline Dutra" sort="Russo, Aline Dutra" uniqKey="Russo A" first="Aline Dutra" last="Russo">Aline Dutra Russo</name>
<name sortKey="Saraiva Pereira, Maria Luiza" sort="Saraiva Pereira, Maria Luiza" uniqKey="Saraiva Pereira M" first="Maria-Luiza" last="Saraiva-Pereira">Maria-Luiza Saraiva-Pereira</name>
<name sortKey="Schumacher Schuh, Artur Francisco" sort="Schumacher Schuh, Artur Francisco" uniqKey="Schumacher Schuh A" first="Artur Francisco" last="Schumacher-Schuh">Artur Francisco Schumacher-Schuh</name>
<name sortKey="Souza, Gabriele Nunes" sort="Souza, Gabriele Nunes" uniqKey="Souza G" first="Gabriele Nunes" last="Souza">Gabriele Nunes Souza</name>
<name sortKey="Torman, Vanessa Bielefeld Leotti" sort="Torman, Vanessa Bielefeld Leotti" uniqKey="Torman V" first="Vanessa Bielefeld Leotti" last="Torman">Vanessa Bielefeld Leotti Torman</name>
</noCountry>
<country name="Brésil"><region name="Rio Grande do Sul"><name sortKey="Saute, Jonas Alex Morales" sort="Saute, Jonas Alex Morales" uniqKey="Saute J" first="Jonas Alex Morales" last="Saute">Jonas Alex Morales Saute</name>
</region>
</country>
</tree>
</affiliations>
</record>
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