ZX008 Clinical Program
DRAVET SYNDROME: A Trial of Two Fixed Doses of ZX008 (Fenlfuramine HCI) in Children and Young Adults with Dravet Syndrome)
This is a multicenter, double-blind, parallel-group, placebo-controlled study to assess the eﬃcacy,
safety, and PK of ZX008 when used as adjunctive therapy for uncontrolled seizures in pediatric and young adult subjects with Dravet syndrome (DS).
Key Inclusion Criteria:
- Clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs.
- Male or non-pregnant, non-lactating female, age 2 to 18 years, as of the day of the Screening Visit.
- Must have a minimum number of convulsive seizures per 4-week period for past 12 weeks prior to screening.
- All medications or interventions for epilepsy must be stable for at least 4 weeks prior to screening and expected to remain stable throughout the study.
- Agree to provide whole blood sample for a broad epilepsy-related gene testing panel.
- No cardiovascular or cardiopulmonary abnormality based on ECHO, ECG or physical examination.
- Parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.
Key Exclusion Criteria:
- Pulmonary arterial hypertension.
- Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
- Current or past history of glaucoma.
- Moderate or severe hepatic impairment.
- Receiving concomitant therapy with: anorectic agents; monoamine-oxidase inhibitors; medications that act via serotonin including serotonin reuptake inhibitors; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.
- Currently receiving or has received stiripentol in the past 21 days prior to Screening.
- Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days.
- Positive result on tetrahydrocannabinol (THC) or cannabidiol (CBD) test at the Screening Visit.
- A clinically significant medical condition, that would interfere with study participation, collection of study data, or pose a risk to the subject.
Contact and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staﬀ using the Contacts provided below.
Please refer to this study by its ClinicalTrials.gov identiﬁer: NCT02682927
|Contact:||A. Castro, MSHS