Health Condition 1: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Oral Perampanel: During the Randomization Phase, participants will receive perampanel at a starting dose of 2 mg/day. Thereafter, the dose will be increased to a maximum target dose of
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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. 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
Exclusion criteria
Exclusion criteria: 1. Prior treatment with perampanel within 30 days of visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in monthly seizure frequency in both the groupsTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of the patients with at least 50% reduction in seizure frequency as compared to baseline in both groups 2. Change in monthly drop attacks in both groups 3. Frequency of treatment emergent adverse effects in both groups Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactIndar Kumar Sharawat
All India Institute of Medical Sciences
Outcome results
None listed