Zonisamide improves wearing-off in Parkinson's disease: A randomized, double-blind study

Background Previously, we reported 50 mg/d zonisamide improved wearing‐off without increasing dyskinesia in patients with Parkinson's disease (PD). Methods To determine the efficacy of zonisamide for treatment of “off” time in PD patients, we conducted a multicenter, randomized, double‐blind, p...

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Published in:Movement disorders 2015-09, Vol.30 (10), p.1343-1350
Main Authors: Murata, Miho, Hasegawa, Kazuko, Kanazawa, Ichiro, Fukasaka, Junichi, Kochi, Kenji, Shimazu, Rieko
Format: Article
Language:English
Subjects:
Aged
Anticonvulsants - administration & dosage
Anticonvulsants - adverse effects
Anticonvulsants - pharmacology
Dopamine Agents - administration & dosage
Dopamine Agents - adverse effects
Dopamine Agents - pharmacology
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Isoxazoles - administration & dosage
Isoxazoles - adverse effects
Isoxazoles - pharmacology
Japan
levodopa
Male
Middle Aged
Movement disorders
Parkinson Disease - drug therapy
Parkinson's disease
randomized controlled trial
Treatment Outcome
wearing-off
zonisamide
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Summary:Background Previously, we reported 50 mg/d zonisamide improved wearing‐off without increasing dyskinesia in patients with Parkinson's disease (PD). Methods To determine the efficacy of zonisamide for treatment of “off” time in PD patients, we conducted a multicenter, randomized, double‐blind, parallel‐group, placebo‐controlled study in Japan. Patients with PD and wearing‐off received placebo for 4 weeks and then were treated for 12 weeks with zonisamide 25 or 50 mg/d or placebo, in addition to their previous therapy. The primary endpoint was the change from baseline in daily “off” time as determined by patients’ diaries at the final assessment. Secondary endpoints included changes from baseline in the total scores of the Unified Parkinson's Disease Rating Scale Parts I, II, III, and IV, the dyskinesia duration, and PDQ‐39 score. Results Of 422 patients enrolled, 389 (131 for placebo, 130 for zonisamide 25 mg, and 128 for zonisamide 50 mg) were randomized, and 354 (120, 119, and 115, respectively) completed the study. The “off” time significantly reduced by 0.719 ± 0.179 h for zonisamide, 50 mg compared with placebo (0.011 ± 0.173 h, P = 0.005). Although the incidence of somnolence was higher for zonisamide (3.1% for zonisamide 25 mg, 6.3% for zonisamide 50 mg) than for placebo (2.3%), the incidences of the other adverse events, including dyskinesia or hallucination, for both zonisamide treatments were comparable to those for placebo. Conclusion The study provides evidence that confirms the efficacy of zonisamide 50 mg/d for reduction in “off” time in PD patients with wearing‐off phenomena. © 2015 International Parkinson and Movement Disorder Society
ISSN:0885-3185
1531-8257
DOI:10.1002/mds.26286