Trial · NCT02682927
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
NCT02682927, 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
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ConductScience Library. A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome. Trials, record NCT02682927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02682927
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
- NCT number
- NCT02682927
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 262 participants, actual
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Conditions
- Dravet Syndrome, Seizure Disorder
- Interventions
- ZX008 (Fenfluramine Hydrochloride), Matching Placebo
- First posted
- 2016-02-17
- Last updated
- 2023-09-28
- Results first posted
- 2022-10-19
- Limitations and caveats
The full results posting consists of the pooled analysis 1 and 2 of the studies with study ID ZX008-1501 and ZX008-1502. Pooled analysis 1 is referenced as Study 1 in the respective statistical analysis plan (SAP) and corresponding clinical study report (CSR). Pooled analysis 2 is referenced as Study 2 in the respective SAP and, due to the timing of regulatory submissions, Study 3 in the corresponding CSR and in this results posting.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | 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 | Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | 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 Greater Than or Equal to 25% (≥25%) Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 25% or greater reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period. |
| Secondary | Percentage of Participants Who Achieved a ≥50% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 50% or greater reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period. |
| Secondary | Percentage of Participants Who Achieved a ≥75% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 75% or greater reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period. |
| Secondary | Percentage of Participants Who Achieved a 100% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 100% reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period. |
| Secondary | Longest Convulsive Seizure-free Interval in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period | During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days) | The longest interval between convulsive seizures was calculated over the entire Titration and Maintenance Period and was derived as the maximum of the number of days between consecutive convulsive seizures. |
| Secondary | Number of Convulsive Seizure-free Days in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period | During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days) | A convulsive seizure free day was defined as a day for which diary data are available and no convulsive seizures were reported. Convulsive seizure free days were taken from the electronic diary data. |
| Secondary | Change From Baseline in Non-convulsive Seizure Frequency to the Combined Titration and Maintenance Period in Each ZX008 Treatment Arm Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | Non-convulsive seizures included focal without clear observable motor signs, absence or atypical absence, myoclonic and atonic. The number of non-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 non-convulsive seizure frequency. |
| Secondary | Change From Baseline in Convulsive + Non-convulsive Seizure Frequency to the Combined Titration and Maintenance Period in Each ZX008 Treatment Arm Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | Total seizure frequency were defined as the combination of convulsive and non-convulsive seizures. Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). Non-convulsive seizures included focal without clear observable motor signs, absence or atypical absence, myoclonic and atonic. The seizure frequency was based on electronic diary data obtained for each participant. The number of all 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 convulsive or non-convulsive seizure frequency. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | seizure frequency per 28 days | MEAN |
| SECONDARY | Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | seizure frequency per 28 days | MEAN |
| SECONDARY | Percentage of Participants Who Achieved Greater Than or Equal to 25% (≥25%) Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants 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 | Percentage of Participants Who Achieved a ≥50% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants 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 | Percentage of Participants Who Achieved a ≥75% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants 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 | Percentage of Participants Who Achieved a 100% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants 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 in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period | During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days) | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | days | MEDIAN |
| SECONDARY | Number of Convulsive Seizure-free Days in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period | During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days) | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | seizure free days | MEDIAN |
| SECONDARY | Change From Baseline in Non-convulsive Seizure Frequency to the Combined Titration and Maintenance Period in Each ZX008 Treatment Arm Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | seizure frequency per 28 days | MEDIAN |
| SECONDARY | Change From Baseline in Convulsive + Non-convulsive Seizure Frequency to the Combined Titration and Maintenance Period in Each ZX008 Treatment Arm Compared to Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | seizure frequency per 28 days | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group618
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo | Study 1: Placebo | -6.71 | Standard Deviation 24.263 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo | Study 1: ZX008 0.8 mg/kg/Day | -13.11 | Standard Deviation 25.500 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo | Study 3: Placebo | 1.54 | Standard Deviation 21.966 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo | Study 3: ZX008 0.8 mg/kg/Day | -3.54 | Standard Deviation 124.132 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo | Study 1: Placebo | -6.71 | Standard Deviation 24.263 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo | Study 1: ZX008 0.2 mg/kg/Day | -18.81 | Standard Deviation 90.640 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo | Study 3: Placebo | 1.54 | Standard Deviation 21.966 | seizure frequency per 28 days | |
| Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo | Study 3: ZX008 0.2 mg/kg/Day | -5.89 | Standard Deviation 84.735 | seizure frequency per 28 days | |
Percentage of Participants Who Achieved Greater Than or Equal to 25% (≥25%) Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | Study 1: Placebo | 35.0 | percentage of participants | ||
Percentage of Participants Who Achieved Greater Than or Equal to 25% (≥25%) Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period | Study 1: ZX008 0.2 mg/kg/Day | 66.7 | percentage of participants |
1 to 10 of 618Source ClinicalTrials.gov
See all 618 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study 1: Placebo | 40 | |
| Overall Study | STARTED | Study 1: ZX008 0.2 mg/kg/Day | 39 | |
| Overall Study | STARTED | Study 1: ZX008 0.8 mg/kg/Day | 40 | |
| Overall Study | STARTED | Study 3: Placebo | 48 | |
| Overall Study | STARTED | Study 3: ZX008 0.2 mg/kg/Day | 46 | |
| Overall Study | STARTED | Study 3: ZX008 0.8 mg/kg/Day | 49 | |
| Overall Study | COMPLETED | Study 1: Placebo | 37 | |
| Overall Study | COMPLETED | Study 1: ZX008 0.2 mg/kg/Day | 39 | |
| Overall Study | COMPLETED | Study 1: ZX008 0.8 mg/kg/Day | 34 | |
| Overall Study | COMPLETED | Study 3: Placebo | 43 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events426
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 | Diarrhoea | Gastrointestinal disorders | Study 1: Placebo | 3 | 40 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Study 1: ZX008 0.2 mg/kg/Day | 12 | 39 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | Study 1: ZX008 0.8 mg/kg/Day | 7 | 40 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Study 3: Placebo | 4 | 48 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Study 3: ZX008 0.2 mg/kg/Day | 7 | 46 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Study 3: ZX008 0.8 mg/kg/Day | 7 | 48 | 7 |
| other | Vomiting | Gastrointestinal disorders | Study 1: Placebo | 4 | 40 | 5 |
| other | Vomiting | Gastrointestinal disorders | Study 1: ZX008 0.2 mg/kg/Day | 4 | 39 | 5 |
| other | Vomiting | Gastrointestinal disorders | Study 1: ZX008 0.8 mg/kg/Day | 3 | 40 | 3 |
| other | Vomiting | Gastrointestinal disorders | Study 3: Placebo | 3 | 48 | 4 |
1 to 10 of 426Source ClinicalTrials.gov
See all 426 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study 1: Placebo | 0 | 40 |
| Total, all-cause mortality | Study 1: ZX008 0.2 mg/kg/Day | 0 | 39 |
| Total, all-cause mortality | Study 1: ZX008 0.8 mg/kg/Day | 0 | 40 |
| Total, all-cause mortality | Study 3: Placebo | 1 | 48 |
| Total, all-cause mortality | Study 3: ZX008 0.2 mg/kg/Day | 0 | 46 |
| Total, all-cause mortality | Study 3: ZX008 0.8 mg/kg/Day | 0 | 48 |
| Total, other adverse events | Study 1: Placebo | 22 | 40 |
| Total, other adverse events | Study 1: ZX008 0.2 mg/kg/Day | 35 | 39 |
| Total, other adverse events | Study 1: ZX008 0.8 mg/kg/Day | 36 | 40 |
| Total, other adverse events | Study 3: Placebo | 37 | 48 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
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 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/NCT02682927
GET https://conductscience.org/api/trials/v1/NCT02682927/registered?page=2