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Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects

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ClinicalTrials.gov Identifier: NCT02721069
Recruitment Status : Unknown
Verified July 2016 by Neurelis, Inc..
Recruitment status was:  Recruiting
First Posted : March 28, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Neurelis, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Repetitive Seizures Breakthrough Seizures Drug: NRL-1 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Month Open-Label, Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects (DIAZ.001.05)
Study Start Date : June 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: NRL-1
Intranasal dose of NRL-1 will be administered at either 5 mg, 10 mg, 15 mg, or 20 mg based on the subject's body weight.
Drug: NRL-1
Other Name: Intranasal diazepam




Primary Outcome Measures :
  1. Safety Assessment through physical and neurological examination including head, ears, eyes, nose, and throat (HEENT), vital signs, laboratories (hematology, serum chemistry, and urinalysis), 12-lead ECGs, and AE assessment. [ Time Frame: 12 months ]
    Assess the safety of diazepam after repeat intranasal doses of NRL-1 administered to Epilepsy subjects who experience frequent breakthrough seizures or Acute Repetitive Seizures, over a 12-month period. Data regarding Treatment Emergent Adverse Events (TEAEs) will be collected in this study. TEAEs are events that are not present at baseline, or if present at baseline, have worsened in severity. AEs will be assessed and followed up during the treatment period and until follow-up telephone contacts.


Secondary Outcome Measures :
  1. Tolerability Assessment by smell test [ Time Frame: Days 30, 90, 150, 210, 270, 330, 365 ]
    assess the tolerability of diazepam after repeat intranasal administration of NRL-1 using the NIH Toolbox for Odor Identification test kit.

  2. Tolerability Assessment by examination of nasal mucosa [ Time Frame: Days 30, 90, 150, 210, 270, 330, 365 ]
    assess the tolerability of diazepam after repeat intranasal administration of NRL-1 by conducting an examination of the nasal mucosa

  3. Caregiver Assessment [ Time Frame: Screening, Days 30, 90, 150, 210, 270, 330 and 365 ]
    To assess the ability of caregivers to administer NRL-1 based on the Directions for Use (DFU)

  4. Quality of Life [ Time Frame: Days 30, 150, 270, 365 ]
    To assess an improvement in the Quality of Life with NRL-1 use as compared to Diastat.



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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721069


Contacts
Contact: Richard Lowenthal, MSc, MBA 858-335-1300 richard@pacificlinkconsulting.com
Contact: Robert Hasson 858-368-9925 rhasson@pacificlinkconsulting.com

Locations
United States, Arkansas
Clinical Trials, Inc. Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Denise Davis    501-227-6179    ddavis@clinicaltrialsinc.com   
Contact: Victor Biton, MD    501-227-6179    vbiton@clinicaltrialsinc.com   
Principal Investigator: Victor Biton, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gregory D Cascino, MD    507-284-2511    gcascino@mayo.edu   
Principal Investigator: Gregory D Cascino, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert E Hogan, MD         
Principal Investigator: Robert E Hogan, MD         
United States, New York
New York University Comprehensive Epilepsy Center Recruiting
New York, New York, United States, 10016
Contact: Blanca Vazquez, MD    201-930-0245      
United States, Pennsylvania
Thomas Jefferson University Hospital Laboratory Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michael Sperling, MD    215-955-1222    michael.sperling@jefferson.edu   
Principal Investigator: Michael Sperling, MD         
Sponsors and Collaborators
Neurelis, Inc.

Responsible Party: Neurelis, Inc.
ClinicalTrials.gov Identifier: NCT02721069     History of Changes
Other Study ID Numbers: DIAZ.001.05
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Neurelis, Inc.:
Seizures
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms