Clinical Trial: 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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dr

Brief Summary: This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who have successfully completed 14 weeks of treatment in the core study (ZX008-1501 and ZX008-1502).

Detailed Summary: This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who have successfully completed 14 weeks of treatment in one of the core studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an extended period of time. Subjects will be permitted to participate in the present study after they complete the final evaluation at Day 113 in one of the core studies. This trial will consist of a 12-month Open-Label Extension (OLE) Treatment Period and a 2-week Post-Dosing Period. Thus, subjects who complete this trial will have been treated with ZX0008 for a minimum of up to 1 year (including their participation in both the core study and this study).
Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Current Primary Outcome: Long-term safety and tolerability as measured by treatment emergent adverse events, including clinical labs, vital signs, and examination findings. [ Time Frame: Pre-baseline Up to 54 weeks ]

Sensitivity of the key efficacy analysis will be assessed for changes in dose or type of concomitant AED medications


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects who achieve reduction from baseline in convulsive seizure frequency [ Time Frame: Baseline up to 54 weeks ]
  • The longest interval between convulsive seizures will be calculated for each subject over the entire open-label treatment period. [ Time Frame: Up to 54 weeks ]


Original Secondary Outcome: Same as current

Information By: Zogenix, Inc.

Dates:
Date Received: June 13, 2016
Date Started: July 2016
Date Completion: August 2017
Last Updated: November 21, 2016
Last Verified: November 2016