An interventional study of Zonisamide Capsules in Parkinson Disease, sponsored by Ain Shams University. Completed at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Zonisamide (ZNS) (1,2-Benzisoxazole-3-methanesulfonamide) is an anti-epileptic drug. In three double blinded placebo controlled studies, ZNS- as an adjunctive treatment- showed beneficial effects on motor symptoms of PD with a low incidence of adverse events. As a result 25 mg daily of ZNS was approved in 2009 in Japan as an adjunctive treatment in PD patients whose condition responded insufficiently to Levodopa treatment.
Most observations of a beneficial effect of ZNS have been in Japanese people, and the antiparkinsonian mechanism of action is unclear. So, ZNS is a promising but still investigational drug to treat PD and more studies are warranted.
this study will investigate the efficacy and tolerability of Zonisamide as an adjunctive treatment in Egyptian patients with advanced PD, including motor fluctuations, levodopa induced dyskinesia and existing nonmotor symptoms. Additionally it investigates its effects on quality of life of PD patients.
Type of Study: Randomized double blinded Placebo controlled study.
Inclusion Criteria:
Exclusion Criteria:
Ethical Considerations:
All of the patients will be informed of the objectives, procedures and possible benefits and risks of the study and will provide written voluntary consent.
The study will conform to the standards of the Ethical Review Committee, Ain Shams University.
Study Procedures:
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 69 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
1 -Age older than 18 years of both male and female genders. 2-Individuals diagnosed with PD based on the presence of 2 of 3 cardinal features \& UK bank criteria for idiopathic Parkinson's disease. 3-Patients with motor complications of PD (Hoehn and Yahr stage 2-3)(on therapy) and at least 2 hours off time.
Exclusion Criteria:
1 -Patients with atypical or secondary Parkinsonism syndromes excluding PD. 2-Patients who could not perform the tests. 3-Women who were or might be pregnant, who did not practice effective contraception and were of childbearing potential, or who were breastfeeding.
30 patients receive oral 25 mg ZNS daily
Drug: Zonisamide Capsules
30 patients receive oral 50 mg ZNS daily
Drug: Zonisamide Capsules
30 patients receive placebo
Drug: Zonisamide Capsules
anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients
Also known as: Convagran
Off motor daily time
assessing change of Off and on time using Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS UPDRS)
Time frame: at 1 and 3 months
levodopa related Dyskinesia
Dyskinesia will also be evaluated with Movement Disorders Society- Unified Dyskinesia Rating Scale (MDS-UDysRS)
Time frame: at 1 and 3 months
Quality of life (daily life activities)
parkinson disease questionnaire-39
Time frame: at 3 months
cognitive outcome
using Montreal cognitive assessment
Time frame: at 3 months
The non-motor symptoms scales
using The non-motor symptoms scales (NMSS)
Time frame: at 1 and 3 months
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University