Dravet syndrome
Conditions
Interventions
Clobazam-added treatment group:Clobazam was added to the patients original optimal antiepileptic regimen for treatment.
Control group:Add placebo treatment to the patients original optimal antiepileptic regimen.
Sponsors
West China Second University Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) Subjects meet the clinical diagnostic criteria for Dravet syndrome (DS) and have a clear diagnosis of DS; (2) Patients with DS aged 1 to 18 years, regardless of gender; (3) The subject has received at least one stabilized dose of at least one anti-seizure medication (ASM) in the month prior to enrollment at baseline, and the seizures are not completely controlled; (4) Subjects or their guardians were able to fill out a fully documented seizure diary and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with clinically significant unstable hepatic, hematologic, renal, cardiovascular, gastrointestinal, or pulmonary disease or persistent malignancy or progressive neurologic disease; (2)Patients who had received clobazam treatment within 3 months prior to study participation; (3)Patients with a history of allergic reactions or significant sensitivity to any component of benzodiazepines or clobazam tablets; (4)Patients with a history of hypersensitivity to any significant CNS-active drug that results in neurobehavioral disorders (e.g., increased biting, scratching, kicking); (5)Patients with severe suicidal ideation or behaviors; (6)Subjects receiving three or more concurrent epilepsy treatments, including ketogenic diet therapy or vagus nerve stimulation (VNS); (7)Subjects were taking carbamazepine, oxcarbazepine, lamotrigine, or other medications known to aggravate seizures before screening; (8) Patients who are uncooperative, unable to communicate, or in the opinion of the investigator are unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with =25%,=50%,=75% and =100% reduction in seizures during the study period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression;Assessment of cognitive function; | — |
Countries
China
Contacts
Public ContactRong Luo
Department of Pediatric Neurology, West China Second University Hospital Sichuan University Chengdu China.
Outcome results
None listed