Trial · NCT02926898
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
NCT02926898, Phase 3, Completed, Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.; results first posted 2022-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome. Trials, record NCT02926898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02926898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
- NCT number
- NCT02926898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 87 participants, actual
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Conditions
- Dravet Syndrome
- Interventions
- ZX008 (Fenfluramine Hydrochloride), Matching Placebo
- First posted
- 2016-10-06
- Last updated
- 2022-11-02
- Results first posted
- 2022-10-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Convulsive Seizure Frequency (CSF) From the Baseline Period (Baseline) to the Combined Titration + Maintenance (T+M) Period | 15 weeks (combined Titration + Maintenance Period) | Monthly (28 day) convulsive seizure frequency (CSF) was based on electronic diary data obtained for each participant. Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). The number of convulsive seizures reported during the entire time interval was divided by the number of nonmissing diary days and the result was then multiplied by 28 to get a 28-day CSF. |
| Secondary | Percentage of Participants Who Achieved ≥ a 50% Reduction in Convulsive Seizure Frequency From Baseline to the Combined Titration + Maintenance Period | 15 weeks (combined Titration + Maintenance Period) | Percentage of participants who achieved ≥ a 50% reduction in convulsive seizure frequency from Baseline compared to the combined Titration + Maintenance Periods in the ZX008 0.5 mg/kg/day vs placebo groups. |
| Secondary | Longest Convulsive Seizure-Free Interval (Days) | 15 weeks (combined Titration + Maintenance Period) | Comparison of the duration of the longest convulsive seizure-free interval (days) during the combined Titration + Maintenance Periods for the ZX008 0.5 mg/kg/day and placebo groups. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Convulsive Seizure Frequency (CSF) From the Baseline Period (Baseline) to the Combined Titration + Maintenance (T+M) Period | 15 weeks (combined Titration + Maintenance Period) | Modified intent-to-treat (mITT) Population, defined as all randomized subjects who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | Convulsive seizures per 28 days | MEAN |
| SECONDARY | Percentage of Participants Who Achieved ≥ a 50% Reduction in Convulsive Seizure Frequency From Baseline to the Combined Titration + Maintenance Period | 15 weeks (combined Titration + Maintenance Period) | Modified intent-to-treat (mITT) Population, defined as all randomized subjects who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | Percentage of participants | NUMBER |
| SECONDARY | Longest Convulsive Seizure-Free Interval (Days) | 15 weeks (combined Titration + Maintenance Period) | Modified intent-to-treat (mITT) Population, defined as all randomized subjects who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Convulsive Seizure Frequency (CSF) From the Baseline Period (Baseline) to the Combined Titration + Maintenance (T+M) Period | Cohort 2: ZX008 0.5 mg/kg/Day | -3.18 | Standard Deviation 44.121 | Convulsive seizures per 28 days | |
| Change in Convulsive Seizure Frequency (CSF) From the Baseline Period (Baseline) to the Combined Titration + Maintenance (T+M) Period | Cohort 2: Matching Placebo | -0.65 | Standard Deviation 8.767 | Convulsive seizures per 28 days | |
| Percentage of Participants Who Achieved ≥ a 50% Reduction in Convulsive Seizure Frequency From Baseline to the Combined Titration + Maintenance Period | Cohort 2: ZX008 0.5 mg/kg/Day | 53.5 | Percentage of participants | ||
| Percentage of Participants Who Achieved ≥ a 50% Reduction in Convulsive Seizure Frequency From Baseline to the Combined Titration + Maintenance Period | Cohort 2: Matching Placebo | 4.5 | Percentage of participants | ||
| Longest Convulsive Seizure-Free Interval (Days) | Cohort 2: ZX008 0.5 mg/kg/Day | 22.0 | Full Range 3.0 to 105.0 | Days | |
| Longest Convulsive Seizure-Free Interval (Days) | Cohort 2: Matching Placebo | 13.0 | Full Range 1.0 to 40.0 | Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 2: ZX008 0.5 mg/kg/Day | 43 | |
| Overall Study | STARTED | Cohort 2: Matching Placebo | 44 | |
| Overall Study | COMPLETED | Cohort 2: ZX008 0.5 mg/kg/Day | 36 | |
| Overall Study | COMPLETED | Cohort 2: Matching Placebo | 41 | |
| Overall Study | NOT COMPLETED | Cohort 2: ZX008 0.5 mg/kg/Day | 7 | |
| Overall Study | NOT COMPLETED | Cohort 2: Matching Placebo | 3 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Cohort 2: ZX008 0.5 mg/kg/Day | 10 | 43 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort 2: Matching Placebo | 3 | 44 | |
| other | Fatigue | General disorders | Cohort 2: ZX008 0.5 mg/kg/Day | 11 | 43 | |
| other | Fatigue | General disorders | Cohort 2: Matching Placebo | 2 | 44 | |
| other | Pyrexia | General disorders | Cohort 2: ZX008 0.5 mg/kg/Day | 11 | 43 | |
| other | Pyrexia | General disorders | Cohort 2: Matching Placebo | 4 | 44 | |
| other | Bronchitis | Infections and infestations | Cohort 2: ZX008 0.5 mg/kg/Day | 5 | 43 | |
| other | Bronchitis | Infections and infestations | Cohort 2: Matching Placebo | 2 | 44 | |
| other | Blood glucose decreased | Investigations | Cohort 2: ZX008 0.5 mg/kg/Day | 6 | 43 | |
| other | Blood glucose decreased | Investigations | Cohort 2: Matching Placebo | 2 | 44 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 2: ZX008 0.5 mg/kg/Day | 0 | 43 |
| Total, all-cause mortality | Cohort 2: Matching Placebo | 0 | 44 |
| Total, other adverse events | Cohort 2: ZX008 0.5 mg/kg/Day | 42 | 43 |
| Total, other adverse events | Cohort 2: Matching Placebo | 42 | 44 |
| Total, serious adverse events | Cohort 2: ZX008 0.5 mg/kg/Day | 6 | 43 |
| Total, serious adverse events | Cohort 2: Matching Placebo | 7 | 44 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 2: ZX008 0.5 mg/kg/Day vs Cohort 2: Matching Placebo: deaths from any cause | Trial comparisons |
| Cohort 2: ZX008 0.5 mg/kg/Day vs Cohort 2: Matching Placebo: serious adverse events | Trial comparisons |
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/NCT02926898
GET https://conductscience.org/api/trials/v1/NCT02926898/events?page=2