A Phase 3 interventional study of ZX008 (Fenfluramine Hydrochloride) in Dravet Syndrome, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.. Terminated at 2 sites in United States. Open to participants aged 2 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. (part of UCB S.A.) · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 11 studies testing fenfluramine in Epilepsies, Myoclonic — 2 open to participants now, 2 under way, none of them phase 3. Fenfluramine · Epilepsies, Myoclonic.
Among the 11 studies testing fenfluramine in Epilepsies, Myoclonic, this one is the 10th largest by enrollment, is one of 2 that started in 2017, is one of 7 in phase 3, and was the 4th registered.
92 studies on the registry are indexed under Epilepsies, Myoclonic; 21 are open to participants now.
Browse Epilepsies, Myoclonic studies →2 of the 11 studies testing fenfluramine in Epilepsies, Myoclonic are open now, in 1 country. Recruiting first, the newest first:
The University of Texas Health Science Center, Houston · Sites in United States
Ages 16+
University of Colorado, Denver · Sites in United States
Ages 12 mo–24 mo
By country, each count listing its studies:
Fenfluramine: first FDA approval 2020 (FINTEPLA), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 14 Epilepsies, Myoclonic studies recruiting now, 3 (21%) set no upper age limit and 10 (71%) stop at 75 or younger; 11 take children under 18; 3 take healthy volunteers.
This study: 2 Years to 35 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2017.
This study's enrollment of 5 is below the median of 31 across 56 interventional studies indexed under Epilepsies, Myoclonic.
Median enrollment 25 across the 11 interventional studies. Of the 9 that completed or were terminated, 5 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 11 have an industry lead sponsor. The 7 most frequent:
This study is registered under Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc., one of the names counted as UCB S.A.. Under that name alone:
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
UCB S.A. has 8 studies filed under Epilepsies, Myoclonic — fewer than ten, so there is no comparison to draw.
2 of the studies testing fenfluramine in Epilepsies, Myoclonic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06598449University of Colorado, DenverAssessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age | 2026-12 |
| NCT07112365The University of Texas Health Science Center, HoustonThe FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project | 2027-09-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies testing fenfluramine in Epilepsies, Myoclonic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is an exploratory sub-study to ZX008-1503 [NCT02823145]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.
This sub study will include up to 20 participants who meet the entry criteria for the main Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app for 12 consecutive weeks. Those invited to participate will undergo all procedures included in the main study during their participation in this sub-study,
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
Drug: ZX008 (Fenfluramine Hydrochloride)
ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome
The assessment of user experience with Embrace watch system included Likert Ease of Use Questionnaire. The questionnaire had 3 items related to use of the Embrace watch, Mate App and Alert App. All the questions were responded on 5-point Likert scale (1-Very difficult, 2-difficult, 3-Neutral, 4-Easy and 5-Very easy). Response to each item on the questionnaire was reported. Responses across all items on the questionnaire were summed to create an overall index with total score of 0 to 15, where higher scores represents the better usability of the device.
Time frame: Approximately 12 weeks
This exploratory sub-study started to enroll participants in July 2017 and concluded in July 2018. Investigating a rare disease in pediatrics, this exploratory sub-study was terminated due to low enrolment. Of the 20 participants the Sponsor attempted to enroll in the study, only 5 participants enrolled and terminated early from the study.
| Milestone | ZX008 |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Caregiver withdrew consent | 2 |
| Withdrew: Child would not keep the watch on | 3 |
The assessment of user experience with Embrace watch system included Likert Ease of Use Questionnaire. The questionnaire had 3 items related to use of the Embrace watch, Mate App and Alert App. All the questions were responded on 5-point Likert scale (1-Very difficult, 2-difficult, 3-Neutral, 4-Easy and 5-Very easy). Response to each item on the questionnaire was reported. Responses across all items on the questionnaire were summed to create an overall index with total score of 0 to 15, where higher scores represents the better usability of the device.
No measurements were reported for this outcome.
Collected over Approximately 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZX008 | — | — | — |
No data will be reported, as the study was investigating a rare disease in pediatrics with a high risk of participant identification due to low enrolment (participant privacy/confidentiality issue).
| Age, Categorical(participants) | ZX008 |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous(years) | ZX008 |
|---|
| Sex: Female, Male(participants) | ZX008 |
|---|---|
| Female | — |
| Male | — |
| Race/Ethnicity, Customized(participants) | ZX008 |
|---|
| Race/Ethnicity, Customized(participants) | ZX008 |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2017 to primary completion in Jul 2018, 11 months.
Results were first posted in Nov 2023, 5 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fenfluramine
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. →