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Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy 400 Real-World-Daten

Noch nicht rekrutierend
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Die klinische Studie NCT06374966 ist eine beobachtungsstudie zur Untersuchung von Partielle Epilepsien und hat den Status noch nicht rekrutierend. Der Start ist für 1. April 2024 geplant, bis 400 Teilnehmer aufgenommen werden. Durchgeführt von Second Affiliated Hospital, School of Medicine, Zhejiang University wird der Abschluss für 1. Dezember 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. April 2024 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
  1. Before starting zonisamide treatment, a 4-week baseline observation period is required, which needs to meet the following criteria: no medication adjustment and at least 2 times of seizure per 4 weeks.
  2. If patients meet the criteria for the baseline period, after the baseline observation period, they are required to complete the blood routine, urine routine, renal function, liver function, ultrasound of the urin...
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Offizieller Titel

Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

Erkrankungen
Partielle Epilepsien
Weitere Studien-IDs
  • 2024-0246
NCT-Nummer
NCT06374966
Studienbeginn (tatsächlich)
2024-04
Zuletzt aktualisiert
2024-04-19
Studienende (vorauss.)
2025-12
Geplante Rekrutierung
400
Studientyp
Beobachtungsstudie
Status
Noch nicht rekrutierend
Stichwörter
epilepsy
zonisamide
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Patients with focal epilepsy
who using zonisamide as an add-on anti-seizure 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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Effective rate at 6 months of treatment
Effective definition: achievement of clinical seizure freedom or \>50% reduction in seizure frequency
6 months
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Effective rate at 3 months of treatment
Effective definition: achievement of clinical seizure freedom or \>50% reduction in seizure frequency
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
6 months
Incidence of side effects
Record the occurrence of side effects in patients and calculate the probability of each side effect occurring
6 months
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
2 Years
Zugelassene Geschlechter
Alle
  1. Meet the International League Against Epilepsy 2017 diagnostic criteria for epilepsy; and the patient's seizures can be clearly classified as partial seizures according to the seizure classification proposed by the International League Against Epilepsy, including simple partial seizures, complex partial seizures, and secondary generalised seizures;
  2. Be greater than or equal to 2 years of age;
  3. Have been on antiepileptic medication, and during the 4-week period of the retrospective baseline period, the patient did not medication adjustments and had at least 2 seizures greater than or equal to 2 seizures per 4-week period;
  4. The patient demonstrated good compliance and was able to complete the scale assessment and record the epilepsy diary on his/her own or with the assistance of a parent;
  5. The informed consent form was signed and dated by the patient or a parent or legal guardian.

  1. Patients who are allergic to zonisamide ;
  2. CT or MRI suggestive of progressive intracranial tumours;
  3. Severe mental retardation or severe psychiatric disorders;
  4. Patients suffering from serious underlying diseases that can affect brain function, such as heart disease, liver disease, renal disease, haematological disorders, malignant tumours, and patients who are immunocompromised;
  5. Ultrasound suggestive of renal stones 6) Pregnant or breastfeeding
Second Affiliated Hospital, School of Medicine, Zhejiang University logoSecond Affiliated Hospital, School of Medicine, Zhejiang University
Zentrale Studienkontakte
Kontakt: Yao Ding, doctorate, 13588015954, [email protected]
10 Studienstandorte in 1 Ländern

Zhejiang

Hangzhou Children's Hospital, Hangzhou, Zhejiang, 310005, China
Zhanli Liu, doctorate, Kontakt, 15968194368, [email protected]
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Shuang Wang, doctorate, Kontakt, 13588817561, [email protected]
Huzhou Third People's Hospital, Huzhou, Zhejiang, 313002, China
Changguo Zhang, doctorate, Kontakt, 15957288075, [email protected]
Jiaxing Second hospital, Jiaxing, Zhejiang, 314099, China
Xiaoxiang Yu, doctorate, Kontakt, 13567340650, [email protected]
Jinhua Second hospital, Jinhua, Zhejiang, 321016, China
Suhong Ye, doctorate, Kontakt, 13757990511, [email protected]
The Fourth Affilicated Hospital of Zhejiang University School of Medicine, Jinhua, Zhejiang, 322099, China
Jiajia Fang, doctorate, Kontakt, 15215880868, [email protected]
Lishui People's Hospital, Lishui, Zhejiang, 323050, China
Likang Lan, doctorate, Kontakt, 18957090351, [email protected]
Ningbo Women And Children's Hospital, Ningbo, Zhejiang, 315012, China
Minghai Huang, doctorate, Kontakt, 13605742462, [email protected]
Ningbo Medical center Lihuili hospital, Ningbo, Zhejiang, 315048, China
Xiaoqin Fan, doctorate, Kontakt, 13685739576, [email protected]
Yuyao People's hospital, Yuyao, Zhejiang, 315499, China