A Phase 1 interventional study of ZX008 0.2 to 0.8 mg/kg/day and Cannabidiol in Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.. Completed at 2 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. (part of UCB S.A.) · Phase 1, Interventional, and Treatment
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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 8th largest by enrollment, is the only one that started in 2018, is the only one in phase 1, and was the 5th 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 18 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. 1 started in 2018.
This study's enrollment of 9 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.
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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 |
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Among the 11 studies testing fenfluramine in Epilepsies, Myoclonic, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).
Key Inclusion Criteria:
Key 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.
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.
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 receive open-label ZX008 (flexible dosing 0.2 mg/kg/day to 0.8 mg/kg/day)
Drug: ZX008 0.2 to 0.8 mg/kg/day · Drug: Cannabidiol
Drug page: Fenfluramine
ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.
Cannabidiol
Adverse Events
Number of adverse events including serious adverse events, number of adverse events leading to study withdrawal
Time frame: Baseline to Day 365
Change in Heart Rate
Change in resting heart rate using standard measures
Time frame: Baseline to Day 365
Change in blood pressure
Change in resting blood pressure using standard measures
Time frame: Baseline to Day 365
Change in temperature
Change in resting temperature using standard measures
Time frame: Baseline to Day 365
Change in respiratory rate
Change in resting respiratory rate using standard measures
Time frame: Baseline to Day 365
Changes in heart rhythm
Changes in heart beat as measured with 12-lead electrocardiogram
Time frame: Baseline to Day 365
Changes in heart valve function
Changes in heart valves as measured with standard echocardiogram
Time frame: Baseline to Day 365
Changes in treatment-emergent body weight and height
Changes in body weight and height by report of BMI in kg/m\^2
Time frame: Baseline to Day 365
Ran from Jan 2018 to primary completion in Jun 2020, 29 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fenfluramine · Cannabidiol
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. →