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• W75858689 abstract "OBJECTIVE: To assess safety and efficacy of Lithium Carbonate (0.5-0.8 mEq/L) in patients with MJD/SCA3. BACKGROUND: MJD/SCA3 is a neurogenetic disorder caused by a CAG repeat expansion at the ATXN3 gene leading to progressive loss of motor coordination that is current untreatable. Lithium was shown to exert neuroprotective effects in pre-clinical models of spinocerebellar ataxias and other polyglutamine disorders. DESIGN/METHODS: A phase II-III double-blind, placebo-controlled, randomized (1:1; blocks of variable sizes, stratified by CAGexp), clinical trial was conducted. Independently ambulatory MJD/SCA3 patients with 10 years or less of disease duration were enrolled from May to September, 2011 in a single center in Rio Grande do Sul, Brazil. Primary end-point of phase II (24 weeks) was the difference in total N of adverse events (AE) and of phase III (48 weeks), the difference in the variation of the NESSCA score (range: 0-40) between groups. RESULTS: 92 patients were recruited and 62 were randomized, 31 to Lithium and 31 to Placebo. Two patients withdrawn the study after baseline assessments and were excluded from intention-to-treat (ITT) analysis. 169 AE were reported after 24 weeks, 49,7% in Lithium and 50,3% in Placebo groups (IC 95% -0.08 to 0.07, p=1.00), with no differences among mild, moderate or severe AEs. After 24 weeks, in ITT (N=60) and per-protocol analysis (N=56), NESSCA worsened 0.93 (IC 95% -0.173 to 2.032, p=0.097) and 0.91(IC 95% -0.212 to 2.032, p=0.110) points more in Placebo than in Lithium treated patients. Non-dominant click test, PATA rate and SCAFI worsened significantly less in Lithium treated patients (p CONCLUSIONS: This study provides Class 1 evidence that Lithium is safe in SCA3/MJD. Interim results on efficacy must be confirmed with the completion of Phase III. Supported by: This trial is registered with ClinicalTrials.gov, NCT01096082. Funding: FIPE-HCPA, CNPq, FAPERGs. Disclosure: Dr. Saute has nothing to disclose. Dr. Souza has nothing to disclose. Dr. Russo has nothing to disclose. Dr. Schumacher-Schuh has nothing to disclose. Dr. Donis has nothing to disclose. Dr. Castilhos has nothing to disclose. Dr. D9Avila has nothing to disclose. Dr. Monte has nothing to disclose. Dr. Furtado has nothing to disclose. Dr. Gheno has nothing to disclose. Dr. Torman has nothing to disclose. Dr. Camey has nothing to disclose. Dr. Saraiva-Pereira has nothing to disclose. Dr. Souza has nothing to disclose. Dr. Portela has nothing to disclose. Dr. Rieder has nothing to disclose. Dr. Jardim has received research support from Europharma." @default.
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• W75858689 date "2013-02-12" @default.
• W75858689 modified "2023-09-26" @default.
• W75858689 title "Safety and Efficacy of Lithium Carbonate for the Treatment of Machado-Joseph Disease (MJD/SCA3): A Phase II-III Randomized, Double-Blind, Placebo-Controlled Trial (S43.004)" @default.
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