Category: Parkinson’s Disease: Clinical Trials
Objective: To compare improvement in tremor at 12 weeks with Zonisamide given in a dose of 25 mg along with other ant- parkinsonian drugs as compared to standard treatment alone in tremor dominant Parkinson’s Disease
Background: In PD patients, compared to bradykinesia and rigidity, tremor responds least to available pharmacological therapy- important issue in Tremor dominant PD patients. Murata et al, in 2007, studied the effect of Zonisamide add on therapy, at a dose of 25 mg, 50mg and100 mg compared with placebo- showed significant improvement in UPDRS part III with 25 mg and 50 mg. Zonisamide has shown improvement in Essential tremor patients.
Method: Single Centre Randomized controlled trial. Randomization done by Sealed envelope randomisation software, allocation was concealed. Permuted block randomisation with variable block sizes of 2,4,6 used. Assessor was blinded to the group allocation. Statistical analysis was done with IBM SPSS software. Mann Whitney U test for non- parametric data, Unpaired t test for parametric data, done for testing significance. Primary outcome-Change in UPDRS III tremor score from baseline. Secondary outcomes-Change from baseline in UPDRS total and subscores,Change from baseline in TETRAS score, Change from baseline on accelerometric tremor analysis.
Results: No significant difference between the groups in the follow-up and change from baseline values of UPDRS tremor scores analysed by Intention to treat(ITT)(p-0.538) as well as per protocol principle (p- 0.77). Best case scenario analysis however showed a significant difference in the follow-up UPDRS tremor scores between the groups (p- 0.001). In the secondary outcomes, there was a significant difference in the change from baseline bradykinesia scores between the groups (p- 0.003). However, per protocol(p-0.98) as well as ITT analysis(p-0.053) done only of the follow-up bradykinesia scores did not show any significant difference between the groups.
Conclusion: There is a preliminary evidence of a beneficial effect on tremor in tremor dominant Parkinson’s disease in best case scenario analysis and on bradykinesia with Zonisamide in a dose of 25 mg. Larger studies are required to confirm these findings. Zonisamide in a dose of 25 mg has a safe side effect profile and is well tolerated among Parkinson’s disease patients.
References: 1. Murata M, Hasegawa K, Kanazawa I, Japan Zonisamide on PD Study Group. Zonisamide improves motor function in Parkinson disease: a randomized, double-blind study. Neurology. 2007 Jan 2;68(1):45–50. 2. Miwa H, Hama K, Kajimoto Y, Kondo T. Effects of zonisamide on experimental tremors in rats. Parkinsonism Relat Disord. 2008;14(1):33–6. 3. Willian G Ondo. Zonisamide for essential tremor. Clin Neuropharmacol. Nov-Dec 2007;30(6):345-9. 4. Rajput AH, Voll A, Rajput ML, Robinson CA, Rajput A. Course in Parkinson disease subtypes: A 39-year clinicopathologic study. Neurology. 2009 Jul 21;73(3):206–12. 5. Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson’s Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218–21.
To cite this abstract in AMA style:K. Pillai, V. Goyal, A. Srivastava, R. Rajan, P. Srivastava, M. Singh, V. V.Y, D. Radhakrishnan, A. Elavarasi, P. Bhat. Randomised Controlled Trial Comparing Efficacy of Zonisamide 25 mg given in addition to standard treatment with standard treatment alone in Tremor dominant Parkinson’s Disease- A Pilot study. [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/randomised-controlled-trial-comparing-efficacy-of-zonisamide-25-mg-given-in-addition-to-standard-treatment-with-standard-treatment-alone-in-tremor-dominant-parkinsons-disease-a-pilot-study/. Accessed December 7, 2023.
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