Trial · NCT05064878
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
NCT05064878, Phase 3, Active not recruiting, Zogenix, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. Trials, record NCT05064878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05064878
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
- NCT number
- NCT05064878
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 87 participants, actual
- Lead sponsor
- Zogenix, Inc.
- Conditions
- CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure, Epileptic Spasm, Refractory Seizures
- Interventions
- Fenfluramine, Placebo
- First posted
- 2021-10-01
- Last updated
- 2026-04-29
- Other registries' IDs
- eudract:2021-003222-76
Source ClinicalTrials.gov
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change from Baseline in Countable Motor Seizure Frequency (CMSF) (Part 1) | Baseline (28 days), Combined Titration and Maintenance (T+M) Periods (14 weeks) | 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. |
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 2) | Up to OLE1 Treatment Period Post-Dose Safety Follow-up Visit 17 (up to 70 weeks) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment Emergent Adverse Events (TEAEs) are defined as any AEs reported on or after the first dose of study medication. |
| Primary | Percentage of Participants With Abnormal Physical Examination Findings (Part 2) | Up to End of Treatment (EoT)/Early Termination (ET) Visit 16 of OLE1 Treatment Period (up to 68 weeks) | Abnormal findings of physical exam that is considered clinically significant by Principal Investigator (PI). |
| Primary | Percentage of Participants With Abnormal Neurological Examination Findings (Part 2) | Up to EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | Abnormal findings of neurological exam that is considered clinically significant by PI. |
| Primary | Percentage of Participants with Positive Response to Self-harm Question (Part 2) | OLE1 Treatment Period Day 1 to OLE1 Treatment Period Post-Dose Safety Follow-up Visit 17 (up to 70 weeks) | |
| Primary | Percentage of Participants with Increase in Valvular Regurgitation from Baseline (except absent to trace) (Part 2) | Baseline (28 days), Cardiac Follow-up Visit 18 (up to 96 weeks) | Valvular regurgitation will be assessed using a 2-dimensional (2-D) Color Doppler Echocardiography (ECHO). |
| Primary | Percentage of Participants with Pulmonary Arterial Hypertension (PASP > 35 mmHg) at any Time During Treatment on Repeat Testing (Part 2) | OLE1 Treatment Period Day 1 to EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory Parameters (Hematology) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory Parameters (Hormones) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory parameters (Chemistry) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05064878
GET https://conductscience.org/api/trials/v1/NCT05064878/registered?page=2