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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT02134366
Eligibility Criteria:
Inclusion Criteria:
•≥ to 18 yrs of age
•Diagnosis of EPC by a Neurologist
Exclusion Criteria:
* Previous exposure to clobazam prior to presentation
* Seizure generalization
* Patients who are intubated and on IV sedation such as Versed®, Propofol or Presedex®.
* Female subjects who are pregnant and/or breast-feeding
* Subject has an unstable and/or serious or psychiatric illness
* Subject has an unstable and/or serious medical illness
* Subject has any of the following but not limited to conditions:
* A life threatening medical condition
* Severe sepsis or septic shock
* Severe Renal impairment
* Severe Hepatic impairment
* Sleep apnea
* Narrow angle glaucoma
* Severe respiratory insufficiency
* Myasthenia gravis
* Metastatic cancer
* Organ failure
* Severe progressive nervous system disease
* A clinically significant EKG abnormality that would be affected by and/or affect the patient's participation in the trial
* Subject has active suicidal ideation at Screening and Baseline visits
* Subject has a history of suicidal thoughts or behaviors, which would be indicated by a positive response to questions 4 and/or 5 on the CSSR-S. Exclusionary actions include but are not limited to:
* Previous intent to act on suicidal ideation with a specific plan
* Previous preparatory acts or behavior
* A previous actual attempt, interrupted attempt or aborted suicide attempt
* Subject has a history of alcohol and/or substance abuse in the previous 12 months, or the subject is unable to refrain from alcohol and/or substance abuse during the study.
* Subject admits to present illicit drug use or has a positive drug screen
* Subject is currently enrolled in or has been enrolled in any clinical trial within the past 30 days
* Subject has a known allergy to any component of the study medication(s)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02134366
Study Brief:
Protocol Section:
NCT02134366