Premium
Lack of efficacy of levetiracetam in oromandibular and cranial dystonia
Author(s) -
Park J. E.,
Srivanitchapoom P.,
Maurer C. W.,
Mathew P.,
Sackett J.,
Paine R.,
Ramos V. L.,
Hallett M.
Publication year - 2017
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/ane.12701
Subject(s) - medicine , levetiracetam , wilcoxon signed rank test , placebo , dystonia , statistical significance , swallowing , adverse effect , surgery , anesthesia , epilepsy , mann–whitney u test , alternative medicine , pathology , psychiatry
Objective To determine the efficacy of levetiracetam in oromandibular or cranial dystonia. Methods We recruited seven subjects with oromandibular or cranial dystonia. Five completed the study, median age was 71 years (range 42‐79 years), median disease duration was 12 years (range 2‐30 years). Participants were randomized to receive levetiracetam or placebo and were then crossed over. They titrated up to a total daily dose of 4000 mg or the maximum tolerated dose over 3 weeks and maintained that dose for another 3 weeks. The primary endpoint was the percent change of the eyes, mouth, speech, and swallowing Burke–Fahn–Marsden ( BFM ) subscores from baseline to weeks 6 and 14. Additional endpoints included the BFM subscore at weeks 3 and 11, and the global dystonia severity ( GDS ) subscore at weeks 3, 6, 11, and 14, as well as all adverse side effects. Results The mean percent increase in the BFM subscore (placebo: 31.25%, levetiracetam: 12.16%) was not significantly different between the two arms according to the Friedman analysis. The Wilcoxon signed‐rank test showed that these percent changes were not significant, indicating that there was no statistical clinical worsening in either arm. The mean percent change of the BFM subscore at weeks 3 and 11 and the mean percent change of the GDS subscore at weeks 3, 6, 11, and 14 were not significantly different between the two arms, and the Wilcoxon signed‐rank test did not show statistical significance. Conclusion Levetiracetam does not appear to be efficacious in patients with oromandibular or cranial dystonia.