Premium
A double‐blind placebo‐controlled trial of zonisamide (zonegran) in the treatment of essential tremor
Author(s) -
Zesiewicz Theresa A.,
Ward Christopher L.,
Hauser Robert A.,
SanchezRamos Juan,
Staffetti Joseph F.,
Sullivan Kelly L.
Publication year - 2006
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.21282
Subject(s) - tolerability , placebo , zonisamide , essential tremor , clinical global impression , medicine , clinical endpoint , rating scale , randomized controlled trial , clinical trial , adverse effect , anesthesia , physical therapy , psychology , physical medicine and rehabilitation , epilepsy , psychiatry , topiramate , pathology , developmental psychology , alternative medicine
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/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. © 2006 Movement Disorder Society