Back to results"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Primary Purpose
Narcolepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
JZP-110
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy
Eligibility Criteria
Major Inclusion Criteria:
- Males and females between 18 and 75 years of age, inclusive
- Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
- Body mass index from 18 to <45 kg/m2
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Major Exclusion Criteria:
- Female subjects who are pregnant, nursing, or lactating
- Moderate or severe sleep apnea on the baseline PSG.
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- History or 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
- History of bariatric surgery within the past year or a history of any gastic bypass procedure
- Presence or history of significant cardiovascular disease
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Use of any medications that could affect the evaluation of cataplexy
- Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Sites / Locations
- Sleep Disorders Center of Alabama
- Pulmonary Associates
- Mayo Clinic in Arizona
- Preferred Research Partners
- So Cal Institute For Respiratory Diseases, Inc.
- Pacific Sleep Medicine
- SDS Clinical Trials
- Stanford University Center for Narcolepsy
- Pacific Research Network, Inc.
- Critical Care Pulmonary & Sleep Associates, LLC
- MD Clinical
- Clinical Research Group of St. Petersburg
- Florida Pediatric Research Institute
- Emory Sleep Center
- NeuroTrials
- SleepMed of Central Georgia
- Northwestern University, Feinberg School of Medicine
- University of Illinois Chicago, College of Nursing
- Veritas Clinical Specialties LTD
- Kentucky Research Group
- The Center for Sleep & Wake Disorders
- Neurocare, Inc.
- Clinical Neurophysiology Services
- Minnesota Lung Center
- University of Missouri
- Clayton Sleep Institute
- Montefiore Medical center
- New York University Medical center
- Duke University Medical Center
- Duke University Medical Center
- Hickory Research Center
- Hickory Research Center, ARSM Research, LLC
- Raleigh Neurology Associates
- North Coast Clinical Trials Inc.
- Sleep Management Institute
- Southwest Cleveland Sleep Research Center
- Cleveland Clinic
- Ohio Sleep Medicine & Neuroscience Institute
- Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
- Lowcountry Lung Critical Care
- Sleep Med of South Carolina
- FutureSearch Trials of Neurology LP
- Todd J. Swick
- Sleep Therapy & Research Center
- Swedish Medical Center
- London Health Sciences Centre
- Toronto Sleep Institute
- Toronto Psychiatric Research Foundation
- Pediatric Sleep Research Inc.
- CARSM Sleep Laboratory & Clinic
- Helsinki Sleep Clinic
- Hospital Roger Salengro
- Universite Paris 5 Hôtel-Dieu
- Hopital Bichat - Claude Bernard
- medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
- Universitaetsklinikum Muenster
- Advanced Sleep Research GmbH
- Studienzentrum Wilhelmshoehe
- Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
- Sleep Wake Center SEIN Heemstede
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
75 mg of JZP-110
150 mg JZP-110
300 mg of JZP-110
Placebo
Arm Description
Once Daily Dosing
Once Daily Dosing
Once Daily Dosing
Once Daily Dosing
Outcomes
Primary Outcome Measures
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Change in ESS Score From Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Secondary Outcome Measures
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
Change in Sleep Latency Time on MWT Trial 1 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Change in Sleep Latency Time on MWT Trial 2 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Change in Sleep Latency Time on MWT Trial 3 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Change in Sleep Latency Time on MWT Trial 4 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Change in Sleep Latency Time on MWT Trial 5 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02348593
Brief Title
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Official Title
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
75 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
150 mg JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
300 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once Daily Dosing
Intervention Type
Drug
Intervention Name(s)
JZP-110
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Primary Outcome Measure Information:
Title
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Description
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Time Frame
Baseline to Week 12
Title
Change in ESS Score From Baseline to Week 12
Description
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Description
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
Time Frame
Baseline to Week 12
Title
Change in Sleep Latency Time on MWT Trial 1 at Week 12
Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame
Change from baseline for sleep latency in MWT during trial 1 at week 12
Title
Change in Sleep Latency Time on MWT Trial 2 at Week 12
Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame
Change from baseline for sleep latency in MWT during trial 2 at week 12
Title
Change in Sleep Latency Time on MWT Trial 3 at Week 12
Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame
Change from baseline for sleep latency in MWT during trial 3 at week 12
Title
Change in Sleep Latency Time on MWT Trial 4 at Week 12
Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame
Change from baseline for sleep latency in MWT during trial 4 at week 12
Title
Change in Sleep Latency Time on MWT Trial 5 at Week 12
Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame
Change from baseline for sleep latency in MWT during trial 5 at week 12
Title
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
Description
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4.
Time Frame
Baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria:
Males and females between 18 and 75 years of age, inclusive
Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent
Major Exclusion Criteria:
Female subjects who are pregnant, nursing, or lactating
Moderate or severe sleep apnea on the baseline PSG.
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
History of bariatric surgery within the past year or a history of any gastic bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Use of any medications that could affect the evaluation of cataplexy
Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Pulmonary Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
So Cal Institute For Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Sleep Medicine
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
SDS Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Center for Narcolepsy
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Critical Care Pulmonary & Sleep Associates, LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Clinical Research Group of St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Florida Pediatric Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory Sleep Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroTrials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
SleepMed of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois Chicago, College of Nursing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Veritas Clinical Specialties LTD
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
The Center for Sleep & Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
24590
Country
United States
Facility Name
Clinical Neurophysiology Services
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Montefiore Medical center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York University Medical center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hickory Research Center
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Hickory Research Center, ARSM Research, LLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
North Coast Clinical Trials Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Sleep Management Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Southwest Cleveland Sleep Research Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Sleep Medicine & Neuroscience Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Lowcountry Lung Critical Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Sleep Med of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
FutureSearch Trials of Neurology LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Todd J. Swick
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Toronto Sleep Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
Facility Name
Toronto Psychiatric Research Foundation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5K 2A7
Country
Canada
Facility Name
Pediatric Sleep Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 3S3
Country
Canada
Facility Name
CARSM Sleep Laboratory & Clinic
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Helsinki Sleep Clinic
City
Helsinki
ZIP/Postal Code
00420
Country
Finland
Facility Name
Hospital Roger Salengro
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Universite Paris 5 Hôtel-Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Studienzentrum Wilhelmshoehe
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Sleep Wake Center SEIN Heemstede
City
Heemstede
State/Province
Noord Holland
ZIP/Postal Code
2103 SW
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34283019
Citation
Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.
Results Reference
derived
PubMed Identifier
33226332
Citation
Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006. Erratum In: J Clin Sleep Med. 2021 Nov 1;17(11):2343.
Results Reference
derived
PubMed Identifier
32588401
Citation
Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.
Results Reference
derived
PubMed Identifier
31926465
Citation
Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.
Results Reference
derived
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"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
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