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March 05, 2013; 80 (10) Article

Octanoic acid in alcohol-responsive essential tremor

A randomized controlled study

Dietrich Haubenberger, Gayle McCrossin, Codrin Lungu, Elaine Considine, Camilo Toro, Fatta B. Nahab, Sungyoung Auh, Peter Buchwald, George J. Grimes, Judith Starling, Gopal Potti, Linda Scheider, Daniel Kalowitz, Daniel Bowen, Andrea Carnie, Mark Hallett
First published February 13, 2013, DOI: https://doi.org/10.1212/WNL.0b013e3182840c4f
Dietrich Haubenberger
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Gayle McCrossin
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Codrin Lungu
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Elaine Considine
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Camilo Toro
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Fatta B. Nahab
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Sungyoung Auh
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Peter Buchwald
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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George J. Grimes
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Judith Starling
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Gopal Potti
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Linda Scheider
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Daniel Kalowitz
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Daniel Bowen
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Andrea Carnie
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Mark Hallett
From the Human Motor Control Section (D.H., G.M., C.L., E.C., L.S., D.K., D.B., A.C., M.H.) and Clinical Neurosciences Program (S.A.), National Institutes of Neurological Disorders and Stroke, NIH, Bethesda; Departments of Neurology (D.H.) and Clinical Pharmacology (D.H.), Medical University of Vienna, Austria; Office of the Clinical Director (C.T.), National Human Genome Research Institute, NIH, Bethesda; Departments of Neurology and Neuroscience (F.B.N.) and Molecular and Cellular Pharmacology (P.B.), University of Miami Miller School of Medicine, Miami, FL; and Pharmaceutical Development Section (G.J.G., J.S., G.P.), NIH, Bethesda, MD.
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Citation
Octanoic acid in alcohol-responsive essential tremor
A randomized controlled study
Dietrich Haubenberger, Gayle McCrossin, Codrin Lungu, Elaine Considine, Camilo Toro, Fatta B. Nahab, Sungyoung Auh, Peter Buchwald, George J. Grimes, Judith Starling, Gopal Potti, Linda Scheider, Daniel Kalowitz, Daniel Bowen, Andrea Carnie, Mark Hallett
Neurology Mar 2013, 80 (10) 933-940; DOI: 10.1212/WNL.0b013e3182840c4f

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Abstract

Objective: To assess safety and efficacy of an oral, single, low dose of octanoic acid (OA) in subjects with alcohol-responsive essential tremor (ET).

Methods: We conducted a double-blind, placebo-controlled, crossover, phase I/II clinical trial evaluating the effect of 4 mg/kg OA in 19 subjects with ET. The primary outcome was accelerometric postural tremor power of the dominant hand 80 minutes after administration. Secondary outcomes included digital spiral analysis, pharmacokinetic sampling, as well as safety measures.

Results: OA was safe and well tolerated. Nonserious adverse events were mild (Common Terminology Criteria for Adverse Events grade 1) and equally present after OA and placebo. At the primary outcome, OA effects were not different from placebo. Secondary outcome analyses of digital spiral analysis, comparison across the entire time course in weighted and nonweighted accelerometry, as well as nondominant hand tremor power did not show a benefit of OA over placebo. The analysis of individual time points showed that OA improved tremor at 300 minutes (dominant hand, F1,16 = 5.49, p = 0.032 vs placebo), with a maximum benefit at 180 minutes after OA (both hands, F1,16 = 6.1, p = 0.025).

Conclusions: Although the effects of OA and placebo at the primary outcome were not different, secondary outcome measures suggest superiority of OA in reducing tremor at later time points, warranting further trials at higher dose levels.

Classification of evidence: This study provides Class I evidence that a single 4-mg/kg dose of OA is not effective in reducing postural tremor in patients with ET at a primary outcome of 80 minutes, but is effective for a secondary outcome after 180 minutes.

GLOSSARY

ET=
essential tremor;
OA=
octanoic acid;
SAE=
serious adverse event

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Supplemental data at www.neurology.org

  • Received July 20, 2012.
  • Accepted November 16, 2012.
  • © 2013 American Academy of Neurology
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