A double-blind placebo-controlled trial of zonisamide (zonegran) in the treatment of essential tremor
Identifieur interne : 004417 ( Main/Merge ); précédent : 004416; suivant : 004418A double-blind placebo-controlled trial of zonisamide (zonegran) in the treatment of essential tremor
Auteurs : Theresa A. Zesiewicz [États-Unis] ; Christopher L. Ward [États-Unis] ; Robert A. Hauser [États-Unis] ; Juan Sanchez-Ramos [États-Unis] ; Joseph F. Staffetti [États-Unis] ; Kelly L. Sullivan [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2007.
Descripteurs français
- Pascal (Inist)
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Abstract
Medical therapy for essential tremor (ET), a common movement disorder, is often inadequate. We performed a double-blind placebo-controlled randomized trial to evaluate the efficacy and tolerability of zonisamide (ZNS), an antiepileptic agent, in treating ET. Twenty patients (mean age, 60 ± 15 years) with ET were randomized to receive ZNS or placebo. ZNS was initiated at a dosage of 100 mg/day and escalated to 200 mg/day at day 14. Patients were evaluated by accelerometry and the Fahn-Tolosa-Marin (FTM) rating scale at baseline and days 14 and 28, as well as the Clinical Global Impression (CGI-C) scale at day 28. At endpoint, subjects assigned to ZNS were taking a mean dosage of 160 ± 50 mg/day. There were no significant improvements in the FTM total score or its subsections. Tremor amplitude as assessed by accelerometry significantly improved in the ZNS group compared to the placebo group at endpoint relative to baseline (-0.50 ± 0.72 vs. 0.30 ± 0.79 m/s2; P = 0.03). On the CGI-C, 60% (n = 6) of patients in the ZNS group felt that their tremor was unchanged, while the remaining patients felt that their tremor was "minimally improved." Thirty percent (n = 3) of patients taking ZNS discontinued the study due to side effects (fatigue, headache, paresthesias) while taking 100 mg per day. ZNS did not provide significant improvements in clinical rating scales at study endpoint compared to placebo and was only modestly well tolerated. ZNS was effective in reducing tremor amplitude as measured by accelerometry.
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Staffetti</name><affiliation wicri:level="4"><inist:fA14 i1="06"><s1>Regional Medical Center, Bayonet Pointe, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Sullivan, Kelly L" sort="Sullivan, Kelly L" uniqKey="Sullivan K" first="Kelly L." last="Sullivan">Kelly L. 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Zesiewicz</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Department of Pharmacology and Experimental Therapeutics, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>National Parkinson Foundation Center of Excellence, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>James A. Haley Veterans Administration Hospital, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Ward, Christopher L" sort="Ward, Christopher L" uniqKey="Ward C" first="Christopher L." last="Ward">Christopher L. Ward</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>National Parkinson Foundation Center of Excellence, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Department of Pharmacology and Experimental Therapeutics, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>National Parkinson Foundation Center of Excellence, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>James A. Haley Veterans Administration Hospital, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Sanchez Ramos, Juan" sort="Sanchez Ramos, Juan" uniqKey="Sanchez Ramos J" first="Juan" last="Sanchez-Ramos">Juan Sanchez-Ramos</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>National Parkinson Foundation Center of Excellence, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>James A. Haley Veterans Administration Hospital, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Staffetti, Joseph F" sort="Staffetti, Joseph F" uniqKey="Staffetti J" first="Joseph F." last="Staffetti">Joseph F. Staffetti</name><affiliation wicri:level="4"><inist:fA14 i1="06"><s1>Regional Medical Center, Bayonet Pointe, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Sullivan, Kelly L" sort="Sullivan, Kelly L" uniqKey="Sullivan K" first="Kelly L." last="Sullivan">Kelly L. Sullivan</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Department of Neurology, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>National Parkinson Foundation Center of Excellence, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Nervous system diseases</term><term>Placebo</term><term>Treatment</term><term>Tremor</term><term>Zonisamide</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Tremblement</term><term>Placebo</term><term>Zonisamide</term><term>Traitement</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Medical therapy for essential tremor (ET), a common movement disorder, is often inadequate. We performed a double-blind placebo-controlled randomized trial to evaluate the efficacy and tolerability of zonisamide (ZNS), an antiepileptic agent, in treating ET. Twenty patients (mean age, 60 ± 15 years) with ET were randomized to receive ZNS or placebo. ZNS was initiated at a dosage of 100 mg/day and escalated to 200 mg/day at day 14. Patients were evaluated by accelerometry and the Fahn-Tolosa-Marin (FTM) rating scale at baseline and days 14 and 28, as well as the Clinical Global Impression (CGI-C) scale at day 28. At endpoint, subjects assigned to ZNS were taking a mean dosage of 160 ± 50 mg/day. There were no significant improvements in the FTM total score or its subsections. Tremor amplitude as assessed by accelerometry significantly improved in the ZNS group compared to the placebo group at endpoint relative to baseline (-0.50 ± 0.72 vs. 0.30 ± 0.79 m/s<sup>2</sup>; P = 0.03). On the CGI-C, 60% (n = 6) of patients in the ZNS group felt that their tremor was unchanged, while the remaining patients felt that their tremor was "minimally improved." Thirty percent (n = 3) of patients taking ZNS discontinued the study due to side effects (fatigue, headache, paresthesias) while taking 100 mg per day. ZNS did not provide significant improvements in clinical rating scales at study endpoint compared to placebo and was only modestly well tolerated. ZNS was effective in reducing tremor amplitude as measured by accelerometry.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Zesiewicz, Theresa A" sort="Zesiewicz, Theresa A" uniqKey="Zesiewicz T" first="Theresa A." last="Zesiewicz">Theresa A. Zesiewicz</name></region><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Sanchez Ramos, Juan" sort="Sanchez Ramos, Juan" uniqKey="Sanchez Ramos J" first="Juan" last="Sanchez-Ramos">Juan Sanchez-Ramos</name><name sortKey="Sanchez Ramos, Juan" sort="Sanchez Ramos, Juan" uniqKey="Sanchez Ramos J" first="Juan" last="Sanchez-Ramos">Juan Sanchez-Ramos</name><name sortKey="Sanchez Ramos, Juan" sort="Sanchez Ramos, Juan" uniqKey="Sanchez Ramos J" first="Juan" last="Sanchez-Ramos">Juan Sanchez-Ramos</name><name sortKey="Sanchez Ramos, Juan" sort="Sanchez Ramos, Juan" uniqKey="Sanchez Ramos J" first="Juan" last="Sanchez-Ramos">Juan Sanchez-Ramos</name><name sortKey="Staffetti, Joseph F" sort="Staffetti, Joseph F" uniqKey="Staffetti J" first="Joseph F." last="Staffetti">Joseph F. Staffetti</name><name sortKey="Sullivan, Kelly L" sort="Sullivan, Kelly L" uniqKey="Sullivan K" first="Kelly L." last="Sullivan">Kelly L. Sullivan</name><name sortKey="Sullivan, Kelly L" sort="Sullivan, Kelly L" uniqKey="Sullivan K" first="Kelly L." last="Sullivan">Kelly L. Sullivan</name><name sortKey="Sullivan, Kelly L" sort="Sullivan, Kelly L" uniqKey="Sullivan K" first="Kelly L." last="Sullivan">Kelly L. Sullivan</name><name sortKey="Ward, Christopher L" sort="Ward, Christopher L" uniqKey="Ward C" first="Christopher L." last="Ward">Christopher L. Ward</name><name sortKey="Ward, Christopher L" sort="Ward, Christopher L" uniqKey="Ward C" first="Christopher L." last="Ward">Christopher L. Ward</name><name sortKey="Ward, Christopher L" sort="Ward, Christopher L" uniqKey="Ward C" first="Christopher L." last="Ward">Christopher L. Ward</name><name sortKey="Zesiewicz, Theresa A" sort="Zesiewicz, Theresa A" uniqKey="Zesiewicz T" first="Theresa A." last="Zesiewicz">Theresa A. Zesiewicz</name><name sortKey="Zesiewicz, Theresa A" sort="Zesiewicz, Theresa A" uniqKey="Zesiewicz T" first="Theresa A." last="Zesiewicz">Theresa A. Zesiewicz</name><name sortKey="Zesiewicz, Theresa A" sort="Zesiewicz, Theresa A" uniqKey="Zesiewicz T" first="Theresa A." last="Zesiewicz">Theresa A. Zesiewicz</name><name sortKey="Zesiewicz, Theresa A" sort="Zesiewicz, Theresa A" uniqKey="Zesiewicz T" first="Theresa A." last="Zesiewicz">Theresa A. Zesiewicz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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