A Comparative, Randomized, Open label, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Rufinamide Tablet Vs. Lamotrigine (Adjunctive Therapy) in the treatment of seizures associated with Lennox-Gastaut syndrome.
Phase 3
- Conditions
- Health Condition 1: G408- Other epilepsy and recurrent seizuresHealth Condition 2: null- Seizures associated with Lennox-Gastaut syndrome
- Registration Number
- CTRI/2010/091/001449
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method