Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects

Therapuetic Areas:Neurology
Age Range:6 - 65
Start Date:April 11, 2016
End Date:March 2019
Contact:Richard Lowenthal, MSc, MBA

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A 12-Month Open-Label, Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects (DIAZ.001.05)

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

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

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
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Robert E Hogan, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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Principal Investigator: Victor Biton, MD
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Phone: 201-930-0245
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Principal Investigator: Michael Sperling, MD
Phone: 215-955-1222
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Principal Investigator: Gregory D Cascino, MD
Phone: 507-284-2511
Rochester, MN
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