A Phase 3 Randomized Double-Blind Placebo-Controlled Fixed-Dose Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension

Brief description of study

The purpose of this study is to learn more about patients with CDKL5 Deficiency Disorder and the potential efficacy of investigational study drug, ZX008. “Investigational” means that the study drug is currently being tested and it has not been approved by U.S. Food and Drug Administration (FDA) or any other Regulatory Authority for patients with CDKL5 Deficiency Disorder. ZX008 study drug is being tested to determine if it will reduce the seizures in subjects with CDKL5 Deficiency Disorder by releasing neurotransmitters (a chemical messenger that carries, boosts, and balances signals between the nerve cells).


Clinical Study Identifier: s21-01683
ClinicalTrials.gov Identifier: NCT05064878
Principal Investigator: Orrin Devinsky.


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