Trial reportInternational journal of clinical pharmacology and therapeutics2019
A phase I, randomized, open-label, single-dose, 3-period crossover study to evaluate the drug-drug interaction between ZX008 (fenfluramine HCl oral solution) and a regimen of stiripentol, clobazam, and valproate in healthy subjects .
Trial report in International journal of clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.
- Efficacy and safety of adjunctive antiseizure medications for dravet syndrome: A systematic review and network meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Trial
- Cardiovascular safety of fenfluramine in the treatment of Dravet syndrome: Analysis of an ongoing long-term open-label safety extension study.Epilepsia · 2020Trial
- Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens: A Randomized Clinical Trial.JAMA neurology · 2020Trial
- Efficacy and safety of fenfluramine in Dravet syndrome: The impact of patient clinical characteristics.Epilepsia open · 2026Article
- Fenfluramine: An Uncommon Cause of False Positive Urine Drug Testing: A Case Report.Annals of the Child Neurology Society · 2025Article
- Expert-Agreed Practical Recommendations on the Use of Fenfluramine in Developmental and Epileptic Encephalopathies Based on Clinical Experience and Literature Review.Neurology and therapy · 2025Review
- Fenfluramine treatment in pediatric patients with Dravet syndrome reduces seizure burden and overall healthcare costs: A retrospective and observational real-world study.Epilepsia open · 2024Observational
- An Update on Stiripentol Mechanisms of Action: A Narrative Review.Advances in therapy · 2024Review
- Review
- Reintroducing Fenfluramine as a Treatment for Seizures: Current Knowledge, Recommendations and Gaps in Understanding.Neuropsychiatric disease and treatment · 2023Review
- Fenfluramine: A Review of Pharmacology, Clinical Efficacy, and Safety in Epilepsy.Children (Basel, Switzerland) · 2022Review
- In vitro evaluation suggests fenfluramine and norfenfluramine are unlikely to act as perpetrators of drug interactions.Pharmacology research & perspectives · 2022Review
- In vitro evaluation of fenfluramine and norfenfluramine as victims of drug interactions.Pharmacology research & perspectives · 2022Review
- Article
- Improving Therapy of Pharmacoresistant Epilepsies: The Role of Fenfluramine.Frontiers in pharmacology · 2022Review
- Expanding the Treatment Landscape for Lennox-Gastaut Syndrome: Current and Future Strategies.CNS drugs · 2021Review
- Fenfluramine in the successful treatment of super-refractory status epilepticus in a patient with Dravet syndrome.Epilepsy & behavior reports · 2021Article
- A 5-HTThe European journal of neuroscience · 2020Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePhase I, open-label, randomized, single-dose, 3-period crossover study assessing pharmacokinetics (PK) and safety of ZX008, a liquid oral formulation of fenfluramine (FFA) under development for adjunctive treatment of Dravet syndrome and Lennox-Gastaut syndrome, administered with and without a combined antiepileptic drug (AED) regimen of stiripentol (STP), valproate (VPA), and clobazam (CLB) (STP regimen). MATERIALS AND
methods26 healthy adults were administered the following treatments: ZX008 0.8 mg/kg; STP 3,500 mg, CLB 20 mg, VPA 25 mg/kg (max. 1,500 mg); and ZX008 0.8 mg/kg + STP regimen. Dose periods were 17 days apart. Blood samples were obtained for 72 hours after drug administration and used to calculate non-compartmental PK parameters.
resultsStatistical bioequivalence-type analysis demonstrated ZX008 had no significant impact on the PK of any drug in the STP regimen, while the STP regimen moderately affected FFA PK. The 3-drug combination increased the geometric mean C
conclusionResults show that the STP regimen had a moderate impact on FFA and norFFA PK and ZX008 had no significant impact on the 3 STP regimen drugs. ZX008 would not be expected to alter the clinical response of patients to this regimen by means of an effect on PK. When administering these drugs together, a downward dose adjustment of ZX008 may be warranted. .
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