Lack of efficacy of levetiracetam in oromandibular and cranial dystonia.
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.


CONCLUSIONS
Levetiracetam does not appear to be efficacious in patients with oromandibular or cranial dystonia.
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.|Department of Neurology, Dongguk University Ilsan Hospital, Goyang, Korea.
J E
JE
Park
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.|Division of Neurology, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
P
P
Srivanitchapoom
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
C W
CW
Maurer
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
P
P
Mathew
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
J
J
Sackett
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.|Food and Drug Administration (FDA) Center for Devices and Radiologic Health, Office of Device Evaluation, Division of Neurological and Physical Medicine, Neurodiagnostics and Neurosurgical Devices Branch, White Oak, MD, USA.
R
R
Paine
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.|Food and Drug Administration (FDA) Center for Devices and Radiologic Health, Office of Device Evaluation, Division of Neurological and Physical Medicine, Neurodiagnostics and Neurosurgical Devices Branch, White Oak, MD, USA.
V L
VL
Ramos
Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
M
M
Hallett
D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D020821:Dystonic Disorders / Q000175:diagnosis* / Q000188:drug therapy*; D005152:Facial Muscles / Q000187:drug effects / Q000473:pathology*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D012886:Skull; D016896:Treatment Outcome
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam
cranial; dystonia; levetiracetam; oromandibular; randomized