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11. Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens A Randomized Clinical Trial

Author

Nabbout, R., Mistry, A., Zuberi, S., Villeneuve, N., Gil-Nagel, A., Sanchez-Carpintero, R., Stephani, U., Laux, L., Wirrell, E., Knupp, K., Chiron, C., Farfel, G., Striano, P, Galer, B. S., Morrison, G., Lock, M., Agarwal, A., and Auvin, S.

Subjects
Male, Pediatrics, medicine.medical_specialty, Drug Resistant Epilepsy, Dose, Adolescent, Fenfluramine, Epilepsies, Myoclonic, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Dravet syndrome, Randomized controlled trial, Double-Blind Method, law, Stiripentol, Medicine, Humans, In patient, 030212 general & internal medicine, Child, business.industry, Dioxolanes, medicine.disease, Child, Preschool, Anticonvulsants, Drug Therapy, Combination, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Selective Serotonin Reuptake Inhibitors, medicine.drug
Abstract

IMPORTANCE Fenfluramine treatment may reduce monthly convulsive seizure frequency in patients with Dravet syndrome who have poor seizure control with their current stiripentol-containing antiepileptic drug regimens. OBJECTIVE To determine whether fenfluramine reduced monthly convulsive seizure frequency relative to placebo in patients with Dravet syndrome who were taking stiripentol-inclusive regimens. DESIGN, SETTING, AND PARTICIPANTS This double-blind, placebo-controlled, parallel-group randomized clinical trial was conducted in multiple centers. Eligible patients were children aged 2 to 18 years with a confirmed clinical diagnosis of Dravet syndrome who were receiving stable, stiripentol-inclusive antiepileptic drug regimens. INTERVENTIONS Patients with 6 or more convulsive seizures during the 6-week baseline period were randomly assigned to receive fenfluramine, 0.4 mg/kg/d (maximum, 17 mg/d), or a placebo. After titration (3 weeks), patients’ assigned dosages were maintained for 12 additional weeks. Caregivers recorded seizures via a daily electronic diary. MAIN OUTCOMES AND MEASURES The primary efficacy end point was the change in mean monthly convulsive seizure frequency between fenfluramine and placebo during the combined titration and maintenance periods relative to baseline. RESULTS A total of 115 eligible patients were identified; of these, 87 patients (mean [SD], age 9.1 [4.8] years; 50 male patients [57%]; mean baseline frequency of seizures, approximately 25 convulsive seizures per month) were enrolled and randomized to fenfluramine, 0.4 mg/kg/d (n = 43) or placebo (n = 44). Patients treated with fenfluramine achieved a 54.0% (95% CI, 35.6%-67.2%; P < .001) greater reduction in mean monthly convulsive seizure frequency than those receiving the placebo. With fenfluramine, 54% of patients demonstrated a clinically meaningful (50%) reduction in monthly convulsive seizure frequency vs 5% with placebo (P < .001). The median (range) longest seizure-free interval was 22 (3.0-105.0) days with fenfluramine and 13 (1.0-40.0) days with placebo (P = .004). The most common adverse events were decreased appetite (19 patients taking fenfluramine [44%] vs 5 taking placebo [11%]), fatigue (11 [26%] vs 2 [5%]), diarrhea (10 [23%] vs 3 [7%]), and pyrexia (11 [26%] vs 4 [9%]). Cardiac monitoring demonstrated no clinical or echocardiographic evidence of valvular heart disease or pulmonary arterial hypertension. CONCLUSIONS AND RELEVANCE Fenfluramine demonstrated significant improvements in monthly convulsive seizure frequency in patients with Dravet syndrome whose conditions were insufficiently controlled with stiripentol-inclusive antiepileptic drug regimens. Fenfluramine was generally well tolerated. Fenfluramine may represent a new treatment option for Dravet syndrome. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02926898

Published
2020

35. Méthodologie des essais cliniques de petits effectifs

Author

Auriche, C., Bernard, J., Boichut, D., Bouhassira, M., Boutouyrie, P., Chaumet-Riffaud, P., Chiron, C., Costa, Y., de Crémiers, F., Etienne, S., Fender, P., Giorgi, R., Girard, F., Girault, D., Grosskopf, C., Gueyffier, F., Labouret, N. Hoog, Juillet, Y., Lechat, P., Leroy, S., Parmentier, L., Ropers, J., Salanave, B., Simon, T., Van Ganse, E., Vray, M., Vray, Muriel, Girault, Danièle, Hoog-Labouret, Natalie, Porcher, Raphaël, and Thalabard, Jean-Christophe

Published
2004
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36. Methodology for Small Clinical Trials

Author

Auriche, C., Bernard, J., Boichut, D., Bouhassira, M., Boutouyrie, P., Chaumet-Riffaud, P., Chiron, C., Costa, Y., de Crémiers, F., Etienne, S., Fender, P., Giorgi, R., Girard, F., Girault, D., Grosskopf, C., Gueyffier, F., Labouret, N. Hoog, Juillet, Y., Lechat, P., Leroy, S., Parmentier, L., Ropers, J., Salanave, B., Simon, T., Van Ganse, E., Vray, M., Vray, Muriel, Girault, Danièle, Hoog-Labouret, Natalie, Porcher, Raphaël, and Thalabard, Jean-Christophe

Published
2004
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40. Perception of impact of Dravet syndrome on children and caregivers in multiple countries: looking beyond seizures

Author

Nabbout, R, Auvin, S, Chiron, C, Thiele, E, Cross, H, Scheffer, IE, Schneider, AL, Guerrini, R, Williamson, N, Irwin, J, Mistry, A, Grimes, R, Bennett, B, Nabbout, R, Auvin, S, Chiron, C, Thiele, E, Cross, H, Scheffer, IE, Schneider, AL, Guerrini, R, Williamson, N, Irwin, J, Mistry, A, Grimes, R, and Bennett, B

Abstract

AIM: To assess the relevance and generalizability across countries of concepts of the impact of Dravet syndrome beyond seizures, as recognized by families. METHOD: Caregivers of children with Dravet syndrome in four countries (Australia [n=8]; USA, UK, and Italy [all n=4]) participated in 1-hour qualitative telephone interviews, identifying key Dravet syndrome concepts. Interviews were recorded, transcribed, and, where necessary, translated into English for thematic analysis. Conceptual saturation was assessed and findings compared to the previously developed French conceptual disease model. RESULTS: The most common seizure types reported by caregivers were tonic-clonic, absence, or focal-impaired awareness (localized/partial). Fever and physical activity were the most commonly reported triggers. Patient-relevant impacts included impairment in cognition, motor skills, communication, social skills, and behavioural functioning. Caregivers consistently reported negative social, physical, and family impacts. Concepts identified in the interviews showed similarity with the French conceptual model. Minor differences between countries are likely to reflect variations in health care systems. INTERPRETATION: Findings in Italy, Australia, UK, and USA confirm that the key impacts of Dravet syndrome on children and caregivers identified in France are generalizable across countries. Key symptom and impact concepts relevant to children and parents should be targeted as critical outcomes in new therapy evaluations. WHAT THIS PAPER ADDS: Relevance of the impact of Dravet syndrome on children and caregivers was confirmed across countries. Patient and caregiver-relevant Dravet syndrome impacts contribute to poorer health-related quality of life. Indirect seizure impacts were reported to be as important as direct impacts. Country-specific differences in concepts probably reflect differences in health care systems.

Published
2019

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