Health Condition 1: null- Naïve patients with generalized tonic-clonic seizures
Conditions
Interventions
Intervention1: Carbamazepine.: Carbamazepine is available as Tegrital® in India and is indicated for the treatment of partial seizures and generalized tonic-clonic seizures, in adults and in children
the dosage should be slowly raised until â?? generally at 400 mg 2 to 3 times daily â?? an optimum response is obtained. In some patients 1600 mg or even 2000 mg daily may be appropriate.
Total study
Sponsors
Novartis India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female out patients > 1 year to 2. Patients or their parent/legally-authorized guardian having given written, informed consent and/or assent to have their data collected after the nature of the trial had been fully explained (according to the local legal regulatory requirements). Patients will not need to consent for taking the drug, as their treatment is decided before entry into the study and is part of their medical care. 3. Patients who agree to follow medication as per local prescribing information of the study drug while participating in the study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible for inclusion in this study: 1. Patients with absence seizure or with juvenile myoclonic seizure. 2. Patients who require two or more anti-epileptic drug. 3. Patients with any psychiatric coexistent illness that may affect the patientâ??s compliance with study procedures. 4. Known hypersensitivity to the study drug, excipients or to drugs of similar chemical classes. 5. Pregnant or nursing (lactating) women. 6. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by local ethics committee) or a barrier method plus a hormonal method. • Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after the study. • Woman are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels 40 mIU/ml [for US only: and estradiol 20 pg/ml] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 7. Any other contra-indication according to local prescribing information for study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in number of seizure episode from baseline as response to Carbamazepine at 24 weeks.Timepoint: â?¢ Change in number of seizure episode from baseline as response to Carbamazepine at 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percentage of patients experiencing (i) â?¥50% reduction in number of seizures per month and (ii) â?¥75% reduction in number of seizures per month after 24 weeks treatment. â?¢ Physicians and subjects global evaluation of improvement in seizure severity & Physicians and subjects global evaluation of tolerability after 24 weeks treatment â?¢ Proportion of patients who discontinue treatment due to unsatisfactory effectiveness or the need for an additional OAED. Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Atul Sharma
Novartis India Limited
Outcome results
None listed