Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study

NCT04182399 | Completed DMC

• 1 other identifier: MD282/2019
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease, zonisamide, motor, fluctuation

Outcome Measures

Primary Outcomes (2)

• Off motor daily time

  assessing change of Off and on time using Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS UPDRS)

  at 1 and 3 months

• levodopa related Dyskinesia

  Dyskinesia will also be evaluated with Movement Disorders Society- Unified Dyskinesia Rating Scale (MDS-UDysRS)

  at 1 and 3 months

Secondary Outcomes (3)

• Quality of life (daily life activities)

  at 3 months

• cognitive outcome

  at 3 months

• The non-motor symptoms scales

  at 1 and 3 months

Study Arms (3)

Patients 25 ZNS

ACTIVE COMPARATOR

30 patients receive oral 25 mg ZNS daily

Drug: Zonisamide Capsules

Patients 50 ZNS

ACTIVE COMPARATOR

30 patients receive oral 50 mg ZNS daily

Drug: Zonisamide Capsules

Patients Placebo

PLACEBO COMPARATOR

30 patients receive placebo

Drug: Zonisamide Capsules

Interventions

Zonisamide Capsules DRUG

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

Patients 25 ZNS; Patients 50 ZNS; Patients Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Department of Neurology, Ain Shams University Hospital

Cairo, Abbasia, 11575, Egypt

Location

Ain Shams Univeristy

Cairo, 11591, Egypt

Location

Related Publications (1)

• Essam M, Hamid E, Abushady E, El-Balkimy M, Antonini A, Shalash A. Role of zonisamide in advanced Parkinson's disease: a randomized placebo-controlled study. Neurol Sci. 2024 Apr;45(4):1725-1734. doi: 10.1007/s10072-024-07396-w. Epub 2024 Feb 20.

  PMID: 38376645 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ali Shalash, PhD

  Department of Neurology, Faculty of Medicine, Ain Shams Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the PD will be randomized to 3 arms. Randomization was done by a research randomization, The copy of the randomization table of patients to the 3 groups was kept with 2 different personnel not working on the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Neurology

Model Details: Eligible patients will be randomly assigned to one of three groups: placebo group , ZNS group 25 mg and ZNS group 50 mg (30 patients each).In ZNS 50 mg group, ZNS will be started with a dose of 25 mg daily for one week then increased to 50 mg once daily to minimize side effects. Randomization was done by a research randomization program (https://www.randomizer.org), The copy of the randomization table of patients to the 3 groups was kept with 2 different personnel not working on the study. Amid to COVID19 and less access to patients in an advanced stage, a crossover design will be included SO patients in: Placebo arm will be randomized to arm 25 mg or 50 mg with at least 1-month washout Arm 25 mg \& arm 50 mg will be shifted to placebo with at least 1 month washout

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: December 2, 2019
• Study Start: April 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

EG (2)