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

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).

Timeline

Start

2022-03-08

Primary completion

2027-11-08

Completion

2027-11-08

Outcome

Met primary endpoint

release “the phase 3 study investigating the safety and efficacy of adjunctive fenfluramine in CDKL5 Deficiency Disorder (CDD) met its primary and key secondary endpoints.” ucb.com ↗

release “including the presentation of positive primary efficacy and safety results from a phase 3 study of FINTEPLA ®▲ (fenfluramine) 1 in CDD” ucb.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fenfluramine	Small molecule	0.5 mg/kg	Oral
Subject	Fenfluramine	Small molecule	0.8 mg/kg	Oral

Indications