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document
A double-blind placebo-controlled trial of zonisamide ( zonegran ) in the treatment of essential tremor . 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 ( 2 ) ; 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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Intervention_Pharmacological
zonisamide ( zonegran )
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Intervention_Pharmacological
zonisamide ( ZNS )
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Intervention_Pharmacological
ZNS
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Intervention_Control
placebo
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Intervention_Pharmacological
ZNS was initiated at a dosage of 100 mg/day and escalated to 200 mg/day at day 14
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Intervention_Pharmacological
ZNS
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Intervention_Pharmacological
ZNS
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Intervention_Pharmacological
ZNS
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Intervention_Pharmacological
ZNS
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Outcome_Physical
essential tremor
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Outcome_Physical
essential tremor ( ET )
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Outcome_Other
efficacy
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Outcome_Other
tolerability
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Outcome_Physical
ET
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Outcome_Physical
ET
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Outcome_Other
Fahn-Tolosa-Marin ( FTM ) rating scale
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Outcome_Other
Clinical Global Impression ( CGI-C ) scale
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Outcome_Other
FTM total score or its subsections
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Outcome_Physical
Tremor amplitude
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Outcome_Physical
tremor
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Outcome_Physical
tremor
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Outcome_Adverse-effects
fatigue
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Outcome_Adverse-effects
headache
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Outcome_Adverse-effects
paresthesias
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Outcome_Other
clinical rating scales
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Outcome_Other
tolerated .
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Outcome_Physical
tremor amplitude
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Participant_Condition
essential tremor ( ET )
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Participant_Sample-size
Twenty patients
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Participant_Age
age , 60 +/- 15 years )
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Participant_Condition
ET