Health Condition 1: G408- Other epilepsy and recurrent seizures Health Condition 2: null- Seizures associated with Lennox-Gastaut syndrome
Conditions
Interventions
Intervention1: Rufinamide Tablets: For children 4 years of age and older: dosage of 10 mg/kg/day administered in 2 equally divided doses, dose should be increased by approximately 10 mg/kg increments
thereafter, increase by a maximum of 25 to 50 mg every 1-2 weeks
usual maintenance doses: 100- 200 mg daily in 1-2 divided doses With enzyme-inducing antiepileptics but not with valproate: 50 mg once daily for 2 week followed by 50 mg bid for 2 week
thereafter, increase by a maximum of 100 mg every 1-2 week
usual maintenance doses: 200-400 mg/day in 2 divided doses
up to 700 mg/day in some patients. With Oxcacarbazepine but no enzyme-inducing or inhibiting antiepileptics: 25 mg once daily for 2 week followed by 50 mg once daily for 2 week
thereafter increase dose by a maximum of 50 - 100 mg every 1 -2 week
usual maintenance doses: 100-200 mg daily in 1-2
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients already receiving the standard drug treatment. 2.Clinical diagnosis of Lennox-Gastaut syndrome confirmed by EEG. 3.Written informed consent by patient. 4.Patients having moderate to severe anxiety. 5.Patient willing to follow up.
Exclusion criteria
Exclusion criteria: 1.Pregnant or nursing females. 2.Patients with severe chronic liver or renal diseases. 3.Individuals having specific phobia. 4.Not on any medication that will interact with lamotrigine and Rufinamide. 5.Obese patients. 6.Have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder, bipolar mood disorder,OCD, psychosurgery 7.Patients participating in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in the frequency of total seizuresTimepoint: week 0,week 2,week 6,week 10, week 14 & week 18;Changes from baseline in the frequency of total seizuresTimepoint: week 0,week 2,week 6,week 10, week 14 & week 18;Changes from baseline in the frequency of total seizuresTimepoint: week 0,week 2,week 6,week 10, week 14 & week 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of efficacy and TolerabiltyTimepoint: week 18;Improvement in signs and symptoms of Headache, Dizziness, Fatigue, Nausea, SleepinessTimepoint: week 0,week 2,week 6,week 10, week 14 & week 18 | — |
Countries
India
Contacts
Public ContactDrShailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed