None listed
Conditions
Interventions
Intervention1: zonisamide 100mg tablets: 100 to 600mg daily in 1 to 3 divided doses for 24 weeks
Control Intervention1: Not applicable: Not applicable
Sponsors
Eisai Pharmaceuticals India Private Limited.
1st Floor, B-Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri East, Mumbai - 400072
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects, 18 to 75 years of age inclusive 2.Treated or untreated subjects suffering from any of the following types of seizures: a.Partial Seizures: Simple Partial Seizures, Complex Partial Seizures & Secondarily generalized tonic clonic seizures b.Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical absence seizures c.Combined seizures (mixed) 3.Subjects having had a computed tomography (CT) or magnetic resonance imaging (MRI) done within the last upto 10 years that ruled a progressive cause of epilepsy. 4.Female subjects without child bearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. 5.Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and enrollment must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug. 6.Patients willing to take the medications as directed, maintain a seizure dairy, report adverse events and willing to come for the follow-ups as per schedule. 7.Willing to comply with the protocol requirements. 8.Able and willing to give the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures). 2.Subjects who have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation related seizures. 3.Subjects with progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination or tumour). 4.Subjects with a history of any significant or currently uncontrolled disease which in the opinion of the investigator will interfere with the conduct of this study or the assessment of safety & efficacy of the study drug. 5.Subjects already receiving zonisamide therapy. 6.Subjects who have received an investigational new drug or device in the past three months before screening and enrollment. 7.Subjects with known hypersensitivity to zonisamide or sulphonamides. 8.Subjects with known abnormal renal function (serum creatinine >1.5 mg/dL) or abnormal hepatic function (Aspartate aminotransferase [AST] and alanine aminotransferase [ALT] >2 times the upper normal limit). 9.Subjects with a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse. 10.Subjects currently taking carbonic anhydrase inhibitors (acetazolamide). 11.Subjects currently taking Mono-Amine Oxidase Inhibitor?s (MAO-I?s). 12.Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant laboratory abnormalities suggestive of metabolic imbalance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of zonisamide based on adverse event reportedand Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale Reduction in Seizure Frequency compared to baseline over 24 weeks treatment periodTimepoint: Total 7 visits from baseline - at 4 weekly intervals - Over 24 weeks Study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Responder Rates and Seizure Freedom with zonisamideTimepoint: Total 7 visits from baseline - at 4 weekly intervals - Over 24 weeks Study period | — |
Countries
India
Contacts
Public ContactDr Amitabh Dash
Regional Medical Advisor
Outcome results
None listed