Efficacy and Safety of Zonisamide as Adjunctive Therapy in Motor Symptoms of Advanced Parkinson's Disease (PD) in Egyptian Population

Abstract

Abstract Background Management of motor complications -especially wearing off- in advanced PD is very challenging. Zonisamide (ZNS) is an antiepileptic drug that showed beneficial effects in motor symptoms of PD in previous studies. Methods To determine the efficacy and safety of ZNS in motor symptoms of advanced PD, we conducted a one month double blinded randomized placebo-controlled crossover study in Egypt. PD patients with Hoehn & Yahr stage ≥ 2 (onstate) and at least 2 hours off time daily were randomized to one of three groups: ZNS 25mg, ZNS 50 mg and placebo. Primary outcome measure was change in off time based on part IV MDS-UPDRS (Movement disorders society-Unified Parkinson’s disease rating scale). Secondary outcome measures were: change in on time based on part IV MDS- UPDRS, change in total score MDS-UPDRS, score of part III MDS-UPDRS. Results Of 69 patients enrolled in the study and underwent randomization to the 3 groups, 49 patients completed one month follow-up. Only 26 patients underwent crossover and 20 patients completed one month follow-up. So, the total number of patients analyzed at 1 month was: 69 patients (25 patients ZNS 25 mg group, 18 patients ZNS 50 mg group and 26 patients placebo group). Both ZNS 25 and 50 mg groups showed significant improvement of total MDS-UPDRS score, Tremors ON score and part 4. Except for sedation, there was no significant adverse effects in both ZNS 25,50 mg groups as compared to placebo. Conclusion ZNS (25,50 mg) is safe and effective in improving motor symptoms of advanced PD as adjunctive therapy.