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

NCT02348632 | Completed Phase 3 Results

• 1 other identifier: 14-005
• Study Type: interventional
• Target: 645
• Locations: 6 countries
• Sites: 80

Brief Summary

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.

Conditions

Narcolepsy; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in Epworth Sleepiness Scale (ESS) Score

  Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. 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. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.

  Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)

Secondary Outcomes (2)

• Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)

  Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

• Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)

  Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

Study Arms (1)

75 mg - 300 mg of JZP-110

OTHER

Once Daily Dosing

Drug: JZP-110

Interventions

JZP-110 DRUG

75 mg - 300 mg of JZP-110

Eligibility Criteria

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

You may qualify if:

• Subject meets one of the following:
• Completed Study 14-002 or 14-003 (Group A)
• Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
• 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
• Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA 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
• 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
• History of bariatric surgery within the past year or a history of roux-en-y 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
• Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
• History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (80)

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

UC San Diego Medical Center

La Jolla, California, 92037, 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

The Research Center of Southern California

Oceanside, California, 92056, 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

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

Critical care Pulmonary & Sleep Associates, LLC

Lakewood, Colorado, 80228, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, 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 Research Inc.

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 at Chicago Nursing School

Chicago, Illinois, 60612, United States

Location

Rowe Neurology Institute RNI - Lenexa

Lenexa, Kansas, 66214, United States

Location

Veritas Clinical Specialties LTD

Topeka, Kansas, 66606, United States

Location

Kentucky Research Group

Louisville, Kentucky, 402318, United States

Location

Advanced Neurodiagnostic Center

Metairie, Louisiana, 70006, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Neurocare, Inc.

Newton, Massachusetts, 24590, United States

Location

Henry Ford Hospital Sleep Disorders & Research Center

Detroit, Michigan, 48202, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

Sleep Medicine & Research center, St. Lukes Hospital

Chesterfield, Missouri, 63017, 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

Clinilabs

New York, New York, 10019, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, 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

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Northcoast Clinical Trials Inc.

Beachwood, Ohio, 44122, United States

Location

Sleep Management Institute

Cincinnati, Ohio, 45245, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45255, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, 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

Center for Sleep and Circadian Neurobiology

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Sleep Medicine Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Lowcountry Lung Critical Care

Charleston, South Carolina, 29406, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Sleep Med of South Carolina Clinical Research Solutions

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

EVMS Sleep Medicine

Norfolk, Virginia, 23510, United States

Location

American Sleep Medicine

Vienna, Virginia, 22182, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Niagra Clinical Research

Niagra Falls, Ontario, L2E 7H9, 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

Unesta Research Center

Tampere, 33200, Finland

Location

University of Turku , Sleep Research Centre

Turku, 20520, Finland

Location

CHU de Dijon

Dijon, 21000, France

Location

Grenoble University Hospital

La Tronche, 38700, France

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

CHU de Poitiers

Poitiers, 86000, France

Location

Somnolab Dortmund

Dortmund, 44263, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Sleep Wake Center SEIN Heemstede

Heemstede, North Holland, 2103 SW, Netherlands

Location

Related Publications (4)

• Malhotra A, Strollo PJ Jr, Pepin JL, Schweitzer P, Lammers GJ, Hedner J, Redline S, Chen D, Chandler P, Bujanover S, Strohl K. Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. Sleep Med. 2022 Dec;100:165-173. doi: 10.1016/j.sleep.2022.08.005. Epub 2022 Aug 14.

  PMID: 36084494 DERIVED

• Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.

  PMID: 34606437 DERIVED

• Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.

  PMID: 33179591 DERIVED

• Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220.

  PMID: 31691827 DERIVED

MeSH Terms

Conditions

Narcolepsy; Sleep Apnea, Obstructive

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Locations

US (63); CA (6); NL (1); FR (6); DE (2); FI (2)