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NCT05064878 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder
A Phase 3 study of Generalized Tonic Clonic Seizure and CDKL5 Deficiency Disorder, sponsored by Zogenix.
- Active
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
- 20
- Study locations
NCT05064878: Active Phase 3 study of Generalized Tonic Clonic Seizure and CDKL5 Deficiency Disorder, sponsored by Zogenix.
NCT05064878 is a Phase 3 study of Generalized Tonic Clonic Seizure and CDKL5 Deficiency Disorder that is active but no longer recruiting, run by Zogenix. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064878, a Phase 3 study of Generalized Tonic Clonic Seizure and CDKL5 Deficiency Disorder, is active but no longer recruiting, sponsored by Zogenix.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
The median percentage change from the Baseline in monthly (per 28 days) CMSF during the combined Titration and Maintenance Periods with the fenfluramine (ZX008) 0.8 mg/kg/day group compared with the placebo group will be reported.
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 |
What the registry record for NCT05064878 still lists
NCT05064878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
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.
NCT05064878 names 20 study sites across 13 states, led by Other, California, Alabama.
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.
What interventions are being tested in trial NCT05064878?
The interventions under investigation include: ZX008 (Fenfluramine Hydrochloride) (DRUG), Matching ZX008 Placebo (DRUG).
Who is sponsoring clinical trial NCT05064878?
This trial is sponsored by Zogenix, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05064878's enrollment target sits among peer trials
87 1743rd of 2000 higher than 256 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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