A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
Public ClinicalTrials.gov record NCT05064878. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT05064878
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Zogenix, Inc.
- Industry
- Enrollment
- 87 participants
Conditions and interventions
Conditions
Interventions
- Fenfluramine Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Year to 35 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 7, 2022
- Primary completion
- Nov 7, 2027
- Completion
- Nov 7, 2027
- Last update posted
- Apr 28, 2026
2022 – 2027
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ep0216 154 | Birmingham | Alabama | 35233 | — |
| Ep0216 144 | Los Angeles | California | 90095 | — |
| Ep0216 101 | San Francisco | California | 94158 | — |
| Ep0216 173 | Aurora | Colorado | 80045 | — |
| Ep0216 149 | Washington D.C. | District of Columbia | 20010 | — |
| Ep0216 157 | Atlanta | Georgia | 30329 | — |
| Ep0216 113 | Brookline | Massachusetts | 02115 | — |
| Ep0216 134 | Detroit | Michigan | 48201 | — |
| Ep0216 166 | Chapel Hill | North Carolina | 27514 | — |
| Ep0216 164 | Cleveland | Ohio | 44195 | — |
| Ep0216 120 | Philadelphia | Pennsylvania | 19104-4318 | — |
| Ep0216 124 | Memphis | Tennessee | 38105 | — |
| Ep0216 171 | Austin | Texas | 78731 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05064878, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05064878 live on ClinicalTrials.gov.