A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome.
- Conditions
- ennox Gastaut SyndromeMedDRA version: 14.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-023505-36-GR
- Lead Sponsor
- Eisai Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Familial short QT syndrome
Prior treatment with rufinamide within 30 days of Baseline Visit or discontinuation of rufinamide treatment due to safety issues related to rufinamide (revised per Amendment 01)
Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal,
renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
Subject with hypersensivity to rufinamide and /or triazole or any of the excipients
Any history of or concomitant medical condition that, in the opinion of the
Investigator, would compromise the subject’s ability to safely complete the study
Scheduled for surgery during the projected course of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method