"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"



Status:Completed
Conditions:Insomnia Sleep Studies, Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:12/12/2018
Start Date:May 2015
End Date:December 2017

Use our guide to learn which trials are right for you!

A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110
in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or
ADX-N05 202.


Major Inclusion Criteria:

1. Subject meets one of the following:

1. Completed Study 14-002 or 14-003 (Group A)

2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)

2. Body mass index from 18 to <45 kg/m2

3. Consent to use a medically acceptable method of contraception

4. Willing and able to provide written informed consent

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating

2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
narcolepsy or OSA that is associated with excessive sleepiness

3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
criteria

4. Presence of any acutely unstable medical condition, behavioral or psychiatric disorder
(including active suicidal ideation), or surgical history that could affect the safety
of the subject or interfere with study efficacy or safety assessments, or the ability
of the subject to complete the trial per the judgment of the Investigator

5. History of bariatric surgery within the past year or a history of roux-en-y procedure

6. Presence or history of significant cardiovascular disease

7. Use of any over the counter (OTC) or prescription medications that could affect the
evaluation of excessive sleepiness

8. Received an investigational drug other than JZP-110 in the past 30 days or five
half-lives (whichever is longer)

9. History of phenylketonuria (PKU) or history of hypersensitivity to
phenylalanine-derived products
We found this trial at
64
sites
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
790 Montclair Road
Birmingham, Alabama 35213
205-599-1020
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
Atlanta, Georgia 30329
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beachwood, Ohio 44122
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45245
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45227
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbia, Missouri 65211
(573) 882-2121
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Dublin, OH
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Glendale, Arizona 85306
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Hickory, North Carolina 28602
?
mi
from
Hickory, NC
Click here to add this to my saved trials
Houston, Texas 77063
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
London,
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10019
?
mi
from
New York, NY
Click here to add this to my saved trials
Newton, Massachusetts 02459
?
mi
from
Newton, MA
Click here to add this to my saved trials
Norfolk, Virginia 23510
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oceanside, California 92054
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oviedo, Florida 32765
?
mi
from
Oviedo, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Redwood City, California 94063
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63143
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33707
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sterling Heights, Michigan 48314
?
mi
from
Sterling Heights, MI
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Topeka, Kansas 66606
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Vienna, Virginia 22182
?
mi
from
Vienna, VA
Click here to add this to my saved trials
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials