"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

NCT02348619 | Completed Phase 3 Results

• 1 other identifier: 14-004
• Study Type: interventional
• Target: 174
• Locations: 5 countries
• Sites: 30

Brief Summary

This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Change in the Maintenance of Wakefulness Test (MWT)

  Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.

  Week 4 to Week 6

• Change in the Epworth Sleepiness Scale (ESS)

  Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6.

  Week 4 to Week 6

Secondary Outcomes (3)

• Patient Global Impression of Change (PGIc)

  Week 4 to Week 6

• Clinical Global Impression of Change (CGIc)

  Week 4 to Week 6

• Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  Week 4 to Week 6

Study Arms (2)

75, 150, 300 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

Placebo

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

Interventions

JZP-110 DRUG

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

• Male or female between 18 and 75 years of age, inclusive
• Diagnosis of OSA according to ICSD-3 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.
• Any other clinically relevant medical, behavioral, or psychiatric disorder other than 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
• 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 or safety assessments or the ability of the subject to complete the trial per the judgment of the principal investigator
• History of bariatric surgery within the past year or a history of any gastric 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
• Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
• Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
• History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (30)

Sleep Disorder Center of Alabama

Birmingham, Alabama, 35213, United States

Location

The Research Center of Southern California

Oceanside, California, 92056, United States

Location

SDS Clinical Trials, INC

Orange, California, 92868, 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

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Broward Research Group, Inc.

Hollywood, Florida, 33024, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

Rowe Neurology Institute RNI - Lenexa

Lenexa, Kansas, 66214, United States

Location

Veritas Clinical Specialities LTD

Topeka, Kansas, 66606, United States

Location

Advanced Neurodiagnostic Ceneter

Metairie, Louisiana, 70006, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

Brigham & Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Center for Sleep & 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

EVMS Sleep Medicine

Norfolk, Virginia, 23510, United States

Location

American Sleep Medicine

Vienna, Virginia, 22182, United States

Location

Tampere University Hospital

Tampere, Södra Finlands Län, 33200, Finland

Location

Turku University Hospital, Sleep Clinic

Turku, Västra Finlands Län, 20520, Finland

Location

Helsinki Sleep Center

Helsinki, 00420, Finland

Location

Grenoble University Hospital

La Tronche, Auvergne-Rhône-Alpes, 38700, France

Location

CHU de Poitiers

Poitiers, Vienne, 86000, France

Location

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Somnolab Dortmund

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

Department of Sleep Medicine

Gӧteborg, Västra Götaland County, SE 413 45, Sweden

Location

Related Publications (1)

• Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.

  PMID: 30471270 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

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

ClinicalTrialDisclosure@JazzPharma.com

2158709177

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: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-09

Locations

FI (3); US (22); SE (1); DE (2); FR (2)