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A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder
NCT05064878 · View on ClinicalTrials.gov ↗
Study Summary
This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
Conditions Studied
Interventions
- DRUG ZX008 (Fenfluramine Hydrochloride)
- DRUG Matching ZX008 Placebo
Study Locations (20)
Other
- Ep0216 2505 — Linz
- Ep0216 804 — Brussels
- Ep0216 801 — Edegem
- Ep0216 2802 — Tbilisi
- Ep0216 902 — Bielefeld
- Ep0216 909 — Kehl-Kork
- Ep0216 908 — Kiel
California
- Ep0216 144 — Los Angeles
- Ep0216 101 — San Francisco
Alabama
- Ep0216 154 — Birmingham
Colorado
- Ep0216 173 — Aurora
District of Columbia
- Ep0216 149 — Washington D.C.
Georgia
- Ep0216 157 — Atlanta
Massachusetts
- Ep0216 113 — Boston
Michigan
- Ep0216 134 — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2027-11-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05064878
The ClinicalTrials.gov registry entry for NCT05064878 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Generalized Tonic Clonic Seizure appearing as the primary indexed condition, and to 2 interventions — of which ZX008 (Fenfluramine Hydrochloride) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05064878 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05064878 about?
NCT05064878 is a clinical study titled "A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder". This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
What is the current status of trial NCT05064878?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2022-03-08. Estimated completion is 2027-11-08.
What conditions does trial NCT05064878 study?
This clinical trial studies the following conditions: Generalized Tonic Clonic Seizure, CDKL5 Deficiency Disorder, Epileptic Spasm, Refractory Seizures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05064878?
The interventions under investigation include: ZX008 (Fenfluramine Hydrochloride) (DRUG), Matching ZX008 Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05064878?
This trial is sponsored by Zogenix, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05064878 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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