Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1
This is a Phase 3, repeat dose, open-label, safety study in Epilepsy subjects who have
 frequent breakthrough seizures or Acute Repetitive Seizures (ARS). NRL-1 will be administered
 as needed to treat bouts of those seizures over a 12-month period of time. Doses will be
 defined as 5 mg, 10 mg, 15 mg, or 20 mg based on the subject's body weight. A diary will be
 used to record the seizure and NRL-1 administration.
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.