Pipeline

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
510-550-8338
ACastro@Zogenix.com

 

Locations: 

ARIZONA

Center for Neurosciences - Tucson
Tucson, Arizona, United States, 85718

CALIFORNIA

Children's Hospital Los Angeles
Los Angeles, California, United States, 90027

Sutter Health – Sacramento
Sacramento, California, United States, 95746

Rady Children's Hospital San Diego
San Diego, California, United States, 92123

University of California San Francisco
San Francisco, California, United States, 94143

COLORADO

The Children's Hospital Colorado Aurora,
Colorado, United States, 80045

FLORIDA

NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States, 32561

Miami Children's Hospital Brian Institute
Miami, Florida, United States, 33155

Neurology and Epilepsy Research Center
Orlando, Florida, United States, 32819

GEORGIA

Panda Neurology
Atlanta, Georgia, United States, 30328

ILLINOIS

Children's Hospital of Chicago
Chicago, Illinois, United States, 60611

MASSACHUSETTS

Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Boston Children's Hospital
Boston, Massachusetts, United States, 02115

 

MINNESOTA

Mayo Clinic
Rochester, Minnesota, United States, 55905

NEW JERSEY

Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States 07601

Saint Barnabus Medical Center
Livingston, New Jersey, United States, 07039

NORTH CAROLINA

OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States, 28203

PENNSYLVANIA

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

TEXAS

Texas Children's Hospital
Houston, Texas, United States, 77030

UTAH

University of Utah
Salt Lake City, Utah, United States, 84113

WASHINGTON

Seattle Children's Hospital
Seattle, Washington, United States, 98105

Swedish Epilepsy Center
Seattle, Washington, United States, 98122