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:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT00356018
Eligibility Criteria:
Inclusion Criteria:1) Patients, age 16 and above, currently taking Divalproex-DR for any seizure disorder; 2) Other AEDs are permitted concurrently, although compliance with these will not be recorded. Other medications for co-morbid disease are permitted, provided no plans for changes in medications used for the treatment of the concomitant disorder are expected.
3\) Patients must demonstrate a 75% or greater compliance rate with DR via calendar during the week of familiarity with the MEMs unit. The threshold value of 75% has been chosen since research shows that people take approximately 75% of their AED(s) as prescribed (13,14), and the same numerical value is frequently used in determining whether or not to retain a patient in clinical Phase 2a-3b industry-sponsored study.
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Exclusion Criteria:1) patients with a recent history of status epilepticus; 2) patients who have refractory or unstable epilepsy; 3) patients with acute illnesses requiring changes in concurrent drugs; 4) patients unwilling to change from their present DR regimen to divalproex-ER or IR-VPA.
5\) Patients unwilling or unable to utilize the MEMs monitoring unit; 6) Pregnant or lactating women.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
99 Years
Study:
NCT00356018
Study Brief:
Protocol Section:
NCT00356018