Study to investigate the palatability, acceptability, pharmacokinetics, safety and tolerability, and treatment compliance of multidoses of ADV6770 as monotherapy or in combination, in children with childhood absence epilepsy.

Phase 1

• Conditions: Children with chilhood absence epilepsy.; MedDRA version: 19.0Level: HLTClassification code 10000332Term: Absence seizuresSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0Level: PTClassification code 10034759Term: Petit mal epilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002313-22-FR
• Lead Sponsor: ADVICENNE PHARMA SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-24
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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 < 2.5 times the upper limit of normal value.
6) Sexually active female of childbearing potential must agree to use a contraceptive method judged effective by the investigator if sexually active and have a negative pregnancy test at inclusion.
7) Parent/legal guardian(s) who has (have) provided a signed written informed consent for the study.
8) Subjects for whom the assent has been collected or searched, when applicable.

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified