Children with chilhood absence epilepsy. MedDRA version: 19.0 Level: HLT Classification code 10000332 Term: Absence seizures System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: PT Classification code 10034759 Term: Petit mal epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ethosuximide
Product Code: ADV6770
Pharmaceutical Form: Granules
INN or Proposed INN: Ethosuximide
CAS Number: 77-67-8
Current Sponsor code: ADV-6770
Other descriptive name: ETHOSUXIMIDE
Sponsors
ADVICENNE PHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects, male or female, between 2 and 17 years old inclusive at study entry. 2) Subjects presenting a childhood absence epilepsy (CAE), diagnosed according to the International League Against Epilepsy Proposal for Revised Classification of Epileptic Seizures ILAE), confirmed by EEG. 3) Subjects who have had typical absence seizures only (seizure-free or with persisting seizures). 4) Subjects already treated and stabilised with an anti-epileptic drug: either by ethosuximide in monotherapy or ethosuximide in combination with valproic acid or lamotrigine. 5) Subjects presenting normal safety laboratory values within three months prior to inclusion or at Day 1: absolute neutrophil count = 1500/mm3, platelets count = 120000/mm3, and transaminases ASAT and ALAT levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects who present other epilepsy syndromes than CAE. 2) Subjects affected by any major disease that may be negatively affected by the study product or that may affect the study product (such as renal impairment, hepatic impairment, haematological disease). 3) Subjects who present contraindications to the administration of the study treatment: known hypersensitivity to succinimides or formulation excipients, rare known hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomatase insufficiency. 4) Subjects treated by medications or consuming products that may interfere with ethosuximide (such as St John’s wort, chelator resins, gastro-intestinal topics, antiacids, adsorbents). 5) Subjects who are not able to evaluate the palatability of the Study treatments. 6) Subjects treated or requiring to be treated with ONLY one EVENING daily dose of ethosuximide at inclusion. 7) Subjects who don’t have coverage by social security.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the palatability of ADV6770 versus ethosuximide syrup.;Secondary Objective: 1) To assess the acceptability of ADV6770 versus ethosuximide syrup. 2) To assess the treatment compliance of ADV6770 versus ethosuximide syrup. 3) To assess the pharmacokinetics of ethosuximide with ADV6770 and syrup formulations. 4) To assess the sustainability of the effects of ADV6770 versus ethosuximide syrup on the absence seizures. 5) To assess pharmacodynamic (PD) profile on gastro-intestinal (GI) tract with Visual Analogue Scales (VAS) for ADV6770 versus ethosuximide syrup. 6) To assess the safety and tolerability of ADV6770 versus ethosuximide syrup. ;Primary end point(s): The primary outcome is the palatability score (taste rating) measured on a 100-mm visual analogical scale VAS (0 mm indicates a really bad taste, 100 mm indicates a really good taste) incorporating 5 facial hedonic features. The outcome is evaluated by the child himself (with the support of the parents or caregiver if needed), at SP I Day 28 (V2) and SP II Day 28 (V3). The score is determined, for all children, in mm from the left end (mean +/- SD) for each investigational medicinal product (IMP) and represents the opinion of the subject for the treatment period.;Timepoint(s) of evaluation of this end point: - Day 28 (V2) - Day 56 (V3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Acceptability endpoints Tests to be done by the children themselves: - evolution of the score of palatability/”taste” - number of subjects who rate the palatability of the IMP = 50 - score of after-taste, - score of easiness of swallowing - score of appropriateness of the volume/quantity of study product - score of treatment preference - score of a spontaneous verbal judgment - score of easiness of administration - rate of willingness to consume again the study product Tests to be done by the parents/caregivers are: - score of palatability perception - score of easiness of dose preparation to obtain the right dose - events of spontaneous rejection or spitting out of the IMP 2) Compliance endpoint - Rate of compliance based on the patient’s surveillance diary and study drug accountability - The percentage of days the patient is considered as compliant within a period is also analysed 3) Pharmacokinetics endpoint Blood PK parameters of ethosuximide, in monotherapy and in combination are calculated after repeated doses, as the average steady-state plasma concentration Cavg and the clearance (Cl) Cavg = dose / (Tau x Cl), with Tau = time interval between 2 successive administrations 4) Sustained effects endpoints - Proportion/number of subjects free from treatment failure - Assessment of the clinical and electroclinical absence seizure condition - Assessment of the correlation between EEG (30 minute recordings) and video/clinical detection of seizures 5) Pharmacodynamics endpoint - Score of gastro-intestinal (GI) tolerability 6) Safety & tolerability endpoints4 - Proportion/number of subjects experiencing treatment emergent adverse events (TEAE) - Changes from baseline in vital signs and laboratory parameters;Timepoint(s) of evaluation of this end point: - D14 of first and secund period of treatment : palatability only - D28 (V2) : all except score of treament preference - D56 (V3) : all | — |
Countries
France
Contacts
Public ContactCatherine CORNU
Centre d'Investigation Clinique, HCL Lyon
Outcome results
None listed