Parkinson DiseaseNCT04182399
Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study
A study testing Zonisamide Capsules in people with Parkinson Disease, run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Zonisamide Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Department of Neurology, Ain Shams University Hospital
Cairo, Abbasia, 11575
Ain Shams Univeristy
Cairo, 11591
About this study
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.
Read the 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:
- Patients with atypical or secondary parkinsonian syndromes excluding PD.
- Patients who could not perform the tests.
- 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
- Parkinson Disease
- Being tested
- Zonisamide Capsules
- Keywords
- Parkinson's disease, zonisamide, motor, fluctuation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide CapsulesDrug
Also called Convagran
anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients
| Study group | Role | What they receive |
|---|---|---|
| Patients 25 ZNS | Active comparator | 30 patients receive oral 25 mg ZNS daily Receives: Drug: Zonisamide Capsules |
| Patients 50 ZNS | Active comparator | 30 patients receive oral 50 mg ZNS daily Receives: Drug: Zonisamide Capsules |
| Patients Placebo | Placebo comparator | 30 patients receive placebo Receives: Drug: Zonisamide Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Off motor daily time
assessing change of Off and on time using Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS UPDRS)
Measured: at 1 and 3 months
levodopa related Dyskinesia
Dyskinesia will also be evaluated with Movement Disorders Society- Unified Dyskinesia Rating Scale (MDS-UDysRS)
Measured: at 1 and 3 months
Secondary outcomes (3)
Quality of life (daily life activities)
parkinson disease questionnaire-39
Measured: at 3 months
cognitive outcome
using Montreal cognitive assessment
Measured: at 3 months
The non-motor symptoms scales
using The non-motor symptoms scales (NMSS)
Measured: at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Apr 2020
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shalash, Ain Shams University
- Investigators
- Ali Shalash, PhD, Principal investigator, Department of Neurology, Faculty of Medicine, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182399
- Sponsor's protocol ID
- MD282/2019
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38376645
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study
- ClinicalTrials.gov ID
- NCT04182399
- Acronym / sponsor ID
- MD282/2019
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, zonisamide, motor, fluctuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Patients with atypical or secondary parkinsonian syndromes excluding PD.
- Patients who could not perform the tests.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients 25 ZNS | Active comparator | Drug: Zonisamide Capsules30 patients receive oral 25 mg ZNS daily |
| Patients 50 ZNS | Active comparator | Drug: Zonisamide Capsules30 patients receive oral 50 mg ZNS daily |
| Patients Placebo | Placebo comparator | Drug: Zonisamide Capsules30 patients receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamide CapsulesAlso: Convagrananti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients | Drug | Patients 25 ZNS, Patients 50 ZNS, Patients Placebo |
Primary outcome
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)
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)
3 secondary outcomes
Quality of life (daily life activities)
Time frame: at 3 months
cognitive outcome
Time frame: at 3 months
The non-motor symptoms scales
Time frame: at 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 38376645Essam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Shalash, PhD principal investigator
Department of Neurology, Faculty of Medicine, Ain Shams Univeristy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zonisamide Capsules in people with Parkinson Disease, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Off motor daily time (time frame: at 1 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.