"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

NCT02348593 | Completed Phase 3 Results

• 1 other identifier: 14-002
• Study Type: interventional
• Target: 239
• Locations: 6 countries
• Sites: 60

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.

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to Week 12

• 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.

  Baseline to Week 12

Secondary Outcomes (7)

• Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12

  Baseline to Week 12

• Change in Sleep Latency Time on MWT Trial 1 at Week 12

  Change from baseline for sleep latency in MWT during trial 1 at week 12

• Change in Sleep Latency Time on MWT Trial 2 at Week 12

  Change from baseline for sleep latency in MWT during trial 2 at week 12

• Change in Sleep Latency Time on MWT Trial 3 at Week 12

  Change from baseline for sleep latency in MWT during trial 3 at week 12

• Change in Sleep Latency Time on MWT Trial 4 at Week 12

  Change from baseline for sleep latency in MWT during trial 4 at week 12

Study Arms (4)

75 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

150 mg JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

300 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

Placebo

PLACEBO COMPARATOR

Once Daily Dosing

Drug: Placebo oral tablet

Interventions

JZP-110 DRUG

150 mg JZP-110; 300 mg of JZP-110; 75 mg of JZP-110

Placebo oral tablet DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (60)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Pulmonary Associates

Glendale, Arizona, 85306, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

So Cal Institute For Respiratory Diseases, Inc.

Los Angeles, California, 90048, United States

Location

Pacific Sleep Medicine

Oceanside, California, 92054, United States

Location

SDS Clinical Trials

Orange, California, 92868, United States

Location

Stanford University Center for Narcolepsy

Redwood City, California, 94063, United States

Location

Pacific Research Network, Inc.

San Diego, California, 92103, United States

Location

Critical Care Pulmonary & Sleep Associates, LLC

Lakewood, Colorado, 80228, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

Florida Pediatric Research Institute

Winter Park, Florida, 32789, United States

Location

Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

NeuroTrials

Atlanta, Georgia, 30342, United States

Location

SleepMed of Central Georgia

Macon, Georgia, 31201, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Illinois Chicago, College of Nursing

Chicago, Illinois, 60612, United States

Location

Veritas Clinical Specialties LTD

Topeka, Kansas, 66606, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Neurocare, Inc.

Newton, Massachusetts, 24590, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

University of Missouri

Columbia, Missouri, 65201, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

New York University Medical center

New York, New York, 10016, United States

Location

Montefiore Medical center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hickory Research Center

Hickory, North Carolina, 28602, United States

Location

Hickory Research Center, ARSM Research, LLC

Huntersville, North Carolina, 28078, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

North Coast Clinical Trials Inc.

Beachwood, Ohio, 44122, United States

Location

Sleep Management Institute

Cincinnati, Ohio, 45245, United States

Location

Southwest Cleveland Sleep Research Center

Cleveland, Ohio, 44130, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Sleep Medicine & Neuroscience Institute

Dublin, Ohio, 43017, United States

Location

Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

Toledo, Ohio, 43606, United States

Location

Lowcountry Lung Critical Care

Charleston, South Carolina, 29406, United States

Location

Sleep Med of South Carolina

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Neurology LP

Austin, Texas, 78731, United States

Location

Todd J. Swick

Houston, Texas, 77063, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Location

Toronto Psychiatric Research Foundation

Toronto, Ontario, M5K 2A7, Canada

Location

Pediatric Sleep Research Inc.

Toronto, Ontario, M6J 3S3, Canada

Location

CARSM Sleep Laboratory & Clinic

Montreal, Quebec, H4J 1C5, Canada

Location

Helsinki Sleep Clinic

Helsinki, 00420, Finland

Location

Hospital Roger Salengro

Lille, 59000, France

Location

Universite Paris 5 Hôtel-Dieu

Paris, 75004, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum

Regensburg, Bavaria, 93053, Germany

Location

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Advanced Sleep Research GmbH

Berlin, 10117, Germany

Location

Studienzentrum Wilhelmshoehe

Kassel, 34131, Germany

Location

Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, 19053, Germany

Location

Sleep Wake Center SEIN Heemstede

Heemstede, North Holland, 2103 SW, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 34283019 DERIVED

• 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.

  PMID: 33226332 DERIVED

• 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.

  PMID: 32588401 DERIVED

• 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.

  PMID: 31926465 DERIVED

MeSH Terms

Conditions

Narcolepsy

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Director, Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

ClinicalTrialDisclosure@JazzPharma.com

215-970-7145

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 28, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Locations

DE (5); FR (3); FI (1); CA (5); NL (1); US (45)