Murata 2020

Current Status of Trial
Completed
Study Aim
Treatment Dementia
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Zonisamide // Placebo
Dosage and Duration
Following a 4-week run-in period, outpatients diagnosed with probable DLB who had developed parkinsonism were randomized to receive oral zonisamide (25 or 50 mg/day) or placebo for 12 weeks, followed by a 40-week open-label extension.
Absolute Number of Participants
351
Health Status/Diagnosis
Lewy Body Demention (DLB) // Parkinson Disease (PD)
Study start date
April 2015
Study completion date
November 2017
Primary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS)
Key Points
"Of 351 patients randomized, 346 (mean age, 77.2 years; 188 males) were included in the modified intention-to-treat population. At Week 12, the group difference (least squares mean +/- SEM) for changes from baseline (vs placebo) in UPDRS part III total score was -2.7 +/- 0.9 (95% confidence interval [CI]: -4.4, -0.9, P = 0.005) in the zonisamide 25-mg group and -2.6 +/- 0.9 (95% CI: -4.4, -0.8, P = 0.005) in the zoni-samide 50-mg group. Adverse events were reported in 47.1%, 48.7%, and 54.5% of patients in the placebo and zonisamide 25and 50-mg groups, and led to treatment discontinuation in 5.0%, 4.3%, and 9.8% of patients, respectively. Conclusion: Daily administration of 25or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB." Murata 2020