An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
Condition: Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Intervention: ZX008 (Fenfluramine Hydrochloride)
Intervention MeSH terms: Fenfluramine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 2 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: seizure; tonic clonic; epilepsy; myoclonic; encephalopathy

Summary:

      This is an international, multicenter, open-label, long-term safety study of ZX008 in
      subjects with Dravet syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day
             of the core study Screening Visit.

          -  Satisfactory completion of the core study in the opinion of the investigator and the
             sponsor.

          -  Subjects who are >18 to ≤35 years of age at the time of screening and did not
             participate in one of the core studies may be eligible for participation.

          -  A documented medical history to support a clinical diagnosis of Dravet syndrome, where
             convulsive seizures are not completely controlled by current antiepileptic drugs.

          -  Parent/caregiver is willing and able to be compliant with diary completion, visit
             schedule and study drug accountability.

          -  Subject's parent/caregiver has been compliant with diary completion during the core
             study, in the opinion of the investigator (eg, at least 90% compliant).

        Key Exclusion Criteria:

          -  Current or past history of cardiovascular or cerebrovascular disease, myocardial
             infarction or stroke.

          -  Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
             and warrants discontinuation of study medication.

          -  Current or past history of glaucoma.

          -  Moderate or severe hepatic impairment.

          -  Receiving concomitant therapy with: centrally-acting anorectic agents;
             monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable
             amount of serotonin agonist or antagonist properties, including serotonin reuptake
             inhibition; atomoxetine, or other centrally-acting noradrenergic agonist;
             cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.

          -  Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or
             phenytoin, or has taken any of these within the past 30 days, as maintenance therapy.

          -  A clinically significant condition, or has had clinically relevant symptoms or a
             clinically significant illness at Visit 1, other than epilepsy, that would negatively
             impact study participation, collection of study data, or pose a risk to the subject.