An observational study in Epilepsies, Partial, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 10 sites in China. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 400 is above the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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As this is a real-world study,we prospectively enrolled patients with focal epilepsy who are suitable for taking zonisamide as an add-on medication
Exclusion Criteria:
who using zonisamide as an add-on anti-seizure drug
Drug: Zonisamide
This is a real-world study，so we prospectively enrolled patients with focal epilepsy suitable for taking zonisamide as an add-on medication
Effective rate at 6 months of treatment
Effective definition: achievement of clinical seizure freedom or \>50% reduction in seizure frequency
Time frame: 6 months
Effective rate at 3 months of treatment
Effective definition: achievement of clinical seizure freedom or \>50% reduction in seizure frequency
Time frame: 3 months
Total time to treatment failure
Total time to treatment failure: number of days from initiation of zonisamide to decision to withdraw zonisamide/add new antiepileptic medication
Time frame: 6 months
Incidence of side effects
Record the occurrence of side effects in patients and calculate the probability of each side effect occurring
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University