Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
Condition: Acute Repetitive Seizures; Breakthrough Seizures
MeSH terms: Epilepsy; Seizures
Intervention: NRL-1
Intervention MeSH terms: Diazepam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Seizures; Epilepsy

Summary:

      This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects between the ages of 6 and 65 years, inclusive.

          2. Written informed consent to participate in the study.

          3. Subject has a clinical diagnosis of Epilepsy and while on a stable regimen of
             anti-epileptic medication, still experiences bouts of seizures (e.g. frequent break
             through seizures or Acute Repetitive Seizures [ARS]), and who, in the opinion of the
             Investigator, may need benzodiazepine intervention for seizure control at least 1 time
             a month on average.

          4. Subject has a qualified caregiver or medical professional available that can
             administer study medication in the event of a seizure.

          5. Subjects having either partial or generalized Epilepsy with motor seizures or seizures
             with clear alteration of awareness.

          6. Female subjects of childbearing potential, defined as having a menstrual cycle and who
             are not surgically sterile or less than two (2) years postmenopausal, must complete a
             pregnancy screen and agree to utilize one of the following forms of contraception
             during the trial and for 21 days after the last dose of study drug: abstinence,
             hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with
             spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum).
             Subjects must have used the same method for at least one (1) month prior to starting
             the study.

          7. No clinically significant abnormal findings in the medical history, on the physical
             examination or electrocardiogram (QTcF<450 msec for males and QTcF<470 msec for
             females).

          8. Subjects and caregivers must agree to return to the study site for all study visits
             and must be willing to comply with all required study procedures.

        Exclusion Criteria:

          1. A history of clinically significant gastrointestinal, renal, hepatic, hematologic,
             endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease,
             or any other condition which, in the opinion of the Investigator, would jeopardize the
             safety of the subject.

          2. Subject has had significant traumatic injury, major surgery or open biopsy within 30
             days prior to study screening.

          3. Subjects with active major depression or a past suicide attempt, or any Suicidal
             Ideation of 3, 4, or 5 or any Suicidal Behavior in Lifetime using Columbia-Suicide
             Severity Rating Scale (C-SSRS). The pediatric C-SSRS should be used for subjects age 6
             to 11. The adult C SSRS should be used for subjects 12 and greater years of age.

          4. A history of allergic or adverse responses to diazepam or any comparable or similar
             product.

          5. Participation in a clinical trial other than protocol DIAZ.001.04 within 30 days prior
             to Day 0. Participation in an observational (non-interventional) study is not excluded
             as long as there are no scheduling conflicts with this study.

          6. Positive serum pregnancy test (ß-hCG) at screening for subjects age 12 or greater.

          7. Positive blood screen for Human immunodeficiency virus (HIV), Hepatitis B surface
             antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of
             abuse, except marijuana use for medical reasons. When marijuana was used for medical
             reasons in the opinion of the investigator, it is not considered as drug abuse and the
             patient can be enrolled even if the marijuana metabolites in the urine revealed as
             positive.