A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome

• Conditions: ennox Gastaut Syndrome; MedDRA version: 14.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-023505-36-IT
• Lead Sponsor: EISAI LTD UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Age = 1 and < 4 years Clinical diagnosis of LGS at screening, which might include the presence of a slow background EEG rhythm, slow spikes-waves pattern (less than 3 Hz), the presence of polyspikes; care should be taken not to include benign myoclonic epilepsy of infancy, subjects with a diagnosis of atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous spike-waves of slow sleep (CSWS) On a fixed dose of one to three concomitant regionally approved antiepileptic drugs (AEDs) for a minimum of 8 weeks prior to randomization with an inadequate response to treatment Consistent seizure documentation (i.e., no uncertainty of the presence of seizures) and AED treatment documentation during the 8 week prerandomization period Written informed consent provided by parent(s)/legal representative(s) Are able to comply with all aspects of the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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

- Familial short QT syndrome - Prior treatment with rufinamide

Study & Design

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