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A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.

NCT05064878 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-04-29

No results posted yet for this study

Summary

This is a Phase 3 Study to examine the efficacy and safety of ZX008 in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).

Conditions

  • CDKL5 Deficiency Disorder
  • Generalized Tonic Clonic Seizure
  • Epileptic Spasm
  • Refractory Seizures

Interventions

DRUG

Fenfluramine

Fenfluramine is supplied as an oral aqueous solution of fenfluramine hydrochloride.

DRUG

Placebo

Matching fenfluramine (hydrochloride) placebo is supplied as an oral solution.

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2027-11-08
Completion
2027-11-08
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Georgia
  • Germany
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Spain
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05064878 on ClinicalTrials.gov