Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04182399 |
| Other study ID # |
MD282/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
