Abstract | OBJECTIVE: METHOD: Individuals with FXTAS aged 34-80 years were enrolled in a randomized, double-blind, placebo-controlled, 1-year trial between September 2007 and August 2012. Inclusion required definite, probable, or possible FXTAS in clinical stages 1-5 according to previously published criteria. Primary outcome measures were the Behavioral Dyscontrol Scale (BDS) score and CATSYS intention tremor severity. RESULTS: Ninety-four participants were randomized from 205 screened; of those, 43 and 45 started treatment with memantine (titrated to 10 mg twice daily) and placebo, respectively. Thirty-four participants receiving memantine and 36 receiving placebo completed the 1-year endpoint assessment (n = 70). Intention-to-treat analysis showed no improvement with respect to intention tremor severity (mean [SD] values with memantine vs placebo: 1.05 [0.73] vs 1.89 [2.19], P = .047) or BDS score (16.12 [5.43] vs 15.72 [3.93], P = .727) at follow-up. Post hoc analyses of participants with early FXTAS (stage ≤ 3), those with late FXTAS (stage > 3), and those in different age groups (≤ 65 years and > 65 years) also indicated no significant improvement. More frequent mild adverse events were observed in the placebo group, while more frequent moderate adverse events occurred in the memantine group (P = .007). CONCLUSION: This randomized, double-blind, placebo-controlled trial of memantine for individuals with FXTAS showed no benefit compared to placebo with respect to the selected outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00584948.
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Authors | Andreea L Seritan, Danh V Nguyen, Yi Mu, Flora Tassone, James A Bourgeois, Andrea Schneider, Jennifer B Cogswell, Kylee R Cook, Maureen A Leehey, Jim Grigsby, John M Olichney, Patrick E Adams, Wendi Legg, Lin Zhang, Paul J Hagerman, Randi J Hagerman |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 75
Issue 3
Pg. 264-71
(Mar 2014)
ISSN: 1555-2101 [Electronic] United States |
PMID | 24345444
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | © Copyright 2013 Physicians Postgraduate Press, Inc. |
Chemical References |
- Antiparkinson Agents
- Placebos
- Memantine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antiparkinson Agents
(administration & dosage, adverse effects, pharmacology)
- Ataxia
(drug therapy)
- Double-Blind Method
- Female
- Fragile X Syndrome
(drug therapy)
- Humans
- Male
- Memantine
(administration & dosage, adverse effects, pharmacology)
- Middle Aged
- Neuropsychological Tests
- Placebos
(administration & dosage, adverse effects, pharmacology)
- Psychiatric Status Rating Scales
- Severity of Illness Index
- Treatment Outcome
- Tremor
(drug therapy)
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