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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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Type of Study: Randomized double blinded Placebo controlled study.

* Study Setting: Movement disorders clinic of neurology department, Ain Shams University Hospitals.
* Study Period : 2 years.
* Study Population: Patients with advanced PD and insufficient response to dopaminergic drugs .

Inclusion Criteria:

* Age older than 18 years of both male and female genders.
* Individuals diagnosed with PD based on the presence of 2 of 3 cardinal features \& United Kingdom bank criteria for idiopathic Parkinson's disease.
* Patients with manifestations of advanced PD defined according to the consensus on the definition of advanced PD.
* Inadequate response to dopaminergic medications due to limitations related to side effects, or levodopa related long-term problems as wearing-off phenomena, "on"-"off" fluctuation, levodopa induced dyskinesia and freezing phenomena, no-"on" and delayed-"on,".

Exclusion Criteria:

1. Patients with atypical or secondary parkinsonian 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.

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:

\- Patients diagnosed with PD will be evaluated for inclusion and exclusion criteria. 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. The dosage and regimen of ongoing antiparkinsonian drugs and other drugs that may affect PD symptoms will remain unchanged one month before and through the treatment period.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Patients 25 ZNS

30 patients receive oral 25 mg ZNS daily

Group Type ACTIVE_COMPARATOR

Zonisamide Capsules

Intervention Type DRUG

anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients

Patients 50 ZNS

30 patients receive oral 50 mg ZNS daily

Group Type ACTIVE_COMPARATOR

Zonisamide Capsules

Intervention Type DRUG

anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients

Patients Placebo

30 patients receive placebo

Group Type PLACEBO_COMPARATOR

Zonisamide Capsules

Intervention Type DRUG

anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients

Interventions

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Zonisamide Capsules

anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients

Intervention Type DRUG

Other Intervention Names

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Convagran

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No