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

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ClinicalTrials.gov Identifier: NCT04182399
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ali Shalash, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Zonisamide Capsules Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

Arm Intervention/treatment
Active Comparator: Patients 25 ZNS
30 patients receive oral 25 mg ZNS daily
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
Other Name: Convagran

Active Comparator: Patients 50 ZNS
30 patients receive oral 50 mg ZNS daily
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
Other Name: Convagran

Placebo Comparator: Patients Placebo
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
Other Name: Convagran




Primary Outcome Measures :
  1. Off motor daily time [ Time Frame: at 1 and 3 months ]
    assessing change of Off and on time using Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS UPDRS)

  2. levodopa related Dyskinesia [ Time Frame: at 1 and 3 months ]
    Dyskinesia will also be evaluated with Movement Disorders Society- Unified Dyskinesia Rating Scale (MDS-UDysRS)


Secondary Outcome Measures :
  1. Quality of life (daily life activities) [ Time Frame: at 3 months ]
    parkinson disease questionnaire-39

  2. cognitive outcome [ Time Frame: at 3 months ]
    using Montreal cognitive assessment

  3. The non-motor symptoms scales [ Time Frame: at 1 and 3 months ]
    using The non-motor symptoms scales (NMSS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182399


Contacts
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Contact: Ali S Shalash, PhD 00201111124815 ali_neuro@yahoo.com
Contact: Mohamed Essam, MD dmohamedesam@gmail.com

Locations
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Egypt
Department of Neurology, Ain Shams University Hospital Recruiting
Cairo, Abbasia, Egypt, 11575
Contact: Ali Shalash, PhD    00201005623036    ali_neuro@yahoo.com   
Contact: Eman Hamid, PhD       emiblue2284@hotmail.com   
Ain Shams Univeristy Recruiting
Cairo, Egypt, 11591
Contact: Ali Shalash, Professor    00201111124815    ali-NEURO@YAHOO.COM   
Contact: AHMED GABER, PROFESSOR       gabarotus@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ali Shalash, PhD Department of Neurology, Faculty of Medicine, Ain Shams Univeristy
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Responsible Party: Ali Shalash, professor of Neurology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04182399    
Other Study ID Numbers: MD282/2019
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ali Shalash, Ain Shams University:
Parkinson's disease, zonisamide, motor, fluctuation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs