tility of perampanel in children with Lennox Gastaut syndrome
- Conditions
- Health Condition 1: G408- Other epilepsy and recurrent seizures
- Registration Number
- CTRI/2023/11/060096
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Participants must have a diagnosis of LGS as evidenced by: more than one type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1; an electroencephalogram (EEG) reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike, and wave pattern <2.5 hertz [Hz]).
2.Aged 4-18 years Participants must have experienced an average of at least 2 drop seizures per week in the 4-week
3.Baseline Period preceding randomization: Participants must have been receiving 1 to 4 concomitant antiepileptic drugs (AEDs) at a stable dose for at least 30 days before Visit 1
1. Prior treatment with perampanel within 30 days of visit 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent Change in monthly seizure frequency in both the groupsTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method 1.Proportion of the patients with at least 50% reduction in seizure frequency as compared to baseline in both groups <br/ ><br>2.Change in monthly drop attacks in both groups <br/ ><br>3.Frequency of treatment emergent adverse effects in both groups <br/ ><br>Timepoint: 24 weeks