Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01462656
Eligibility Criteria:
Inclusion Criteria:
* Prospective Cohort (indicated use)
* Patients with at least one medical claim carrying an ICD-9 code for epilepsy. The following ICD-9 codes will be used to identify patients with epilepsy:
* 345 Epilepsy and recurrent seizures
* 780.3 Convulsions
* 780.39 Other convulsions
* Patients initiating a new AED monotherapy\* or polytherapy\*\* following the launch of EZG.
* At least 6 months of continuous healthcare plan enrolment before initiation of the new AED (monotherapy or polytherapy) following the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
* Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).
* Prospective Cohort (non-indicated use)
* Epilepsy patients initiating EZG AED monotherapy
* Patients \<18 years old initiating EZG for epilepsy
* Patients initiating EZG for any reason other than epilepsy
* Patients initiating EZG AED polytherapy with less than six months of continuous healthcare enrolment who were excluded from the cohort described under the primary objective
* Retrospective Cohort
* Patients with at least one medical claim carrying an ICD-9 code for epilepsy in the three year period preceding the launch of EZG. The following ICD-9 codes will be used to identify patients with epilepsy:
* 345 Epilepsy and recurrent seizures
* 780.3 Convulsions
* 780.39 Other convulsions
* Patients initiating a new AED monotherapy\* or polytherapy\*\* regimen in the three year period preceding the launch of EZG.
* At least 6 months of continuous healthcare plan enrolment before initiation of the new AED regimen (monotherapy or polytherapy) during the three year period preceding the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
* Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).
* This will include patients substituting an AED monotherapy. \*\*This will include patients switching from a monotherapy to polytherapy regimen and those substituting an AED within an existing polytherapy regimen.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01462656
Study Brief:
Protocol Section:
NCT01462656