CTRI/2010/091/001239
Recruiting
Phase 4
The prospective, open-label, multicentre, non-comparative, observational post-marketing surveillance study evaluating efficacy and tolerability of TRIoptal® (OXcarbazepine) in children and adolescents with newly diagnosed partial seizures or generalized tonic-clonic seizures as monotherapy in routine clinical practice
ovartis India LimitedSandoz House, 5th floorShivsagar EstateDr. Annie Besant RoadIndia0 sites500 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis India LimitedSandoz House, 5th floorShivsagar EstateDr. Annie Besant RoadIndia
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female children \& adolescents between 1 month to 18 years of age (both inclusive) with newly diagnosed epilepsy of the following types:
- •2\.Partial seizures (including the seizure subtypes of simple and complex partial seizures, and partial seizures evolving to secondarily generalized seizures)
- •or Generalized tonic clonic seizures
- •3\. Patients or their parent/legally\-authorized guardian having given written, informed consent and/or assent after the nature of the trial had been fully explained (according to the local legal regulatory requirements)
Exclusion Criteria
- •1\.Age less than 1 month or greater than 18 years;
- •2\.Patients with evidence of severe or unstable physical illness or medical condition which would prevent them from participating in the clinical trial;
- •3\.Any clinically significant abnormal laboratory findings during screening which remain abnormal upon repeated measurement;
- •4\.Known hypersensitivity to Oxcarbazepine or any of the components in the formulation;
- •5\. Any psychiatric coexistent illness that may affect the patient?s compliance with study procedures;
- •6\. Patients with other indications than partial seizures, or generalized tonic\-clonic seizures;
- •7\. Parents or Guardians who are not willing to sign the Informed Consent form.
- •8\. Females of child bearing potential who are planning to become pregnant or who are pregnant.
Outcomes
Primary Outcomes
Not specified
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