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A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol

NCT03467113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-12-01

No results posted yet for this study

Summary

This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).

Conditions

Interventions

DRUG

ZX008 0.2 to 0.8 mg/kg/day

ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.

DRUG

Cannabidiol

Cannabidiol

Sponsors & Collaborators

  • Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2020-06-24
Completion
2020-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467113 on ClinicalTrials.gov