Study to evaluate the effectiveness and tolerability of Carbamazepine (TEgrital®) as Monotherapy in patients with generalized tonic-clonic seizures.
- Conditions
- Health Condition 1: null- Naïve patients with generalized tonic-clonic seizures
- Registration Number
- CTRI/2013/10/004071
- Lead Sponsor
- ovartis India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 493
1.Male and female out patients > 1 year to < 60 years of age with diagnosis of generalized tonic-clonic seizures that have been prescribed Carbamazepine as monotherapy (in OAED naïve patients) as per local prescribing information.
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. <br/ ><br>â?¢Physicians and subjects global evaluation of improvement in seizure severity & Physicians and subjects global evaluation of tolerability after 24 weeks treatment <br/ ><br>â?¢Proportion of patients who discontinue treatment due to unsatisfactory effectiveness or the need for an additional OAED. <br/ ><br>Timepoint: 24 weeks