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

Obstructive Sleep Apnea Clinical Trial

— OSA  

Official title:

A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, 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 Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348619
• Other study ID #: 14-004
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2019
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Major Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive

2. Diagnosis of OSA according to ICSD-3 criteria

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

4. Consent to use a medically acceptable method of contraception

5. 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 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. 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

5. History of bariatric surgery within the past year or a history of any gastric bypass 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 in the past 30 days or five half-lives (whichever is longer)

9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)

10. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness

Intervention

Drug:
• JZP-110

Locations

Country	Name	City	State
Finland	Helsinki Sleep Center	Helsinki
Finland	Tampere University Hospital	Tampere	Södra Finlands Län
Finland	Turku University Hospital, Sleep Clinic	Turku	Västra Finlands Län
France	Grenoble University Hospital	La Tronche	Rhône-Alpes
France	CHU de Poitiers	Poitiers	Vienne
Germany	Somnolab Dortmund	Dortmund	Nordrhein-Westfalen
Germany	Klinische Forschung Schwerin GmbH	Schwerin	Mecklenburg-Vorpommern
Sweden	Department of Sleep Medicine	G?teborg	Västra Götalands Län
United States	Emory Sleep Center	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Sleep Disorder Center of Alabama	Birmingham	Alabama
United States	Brigham & Womens Hospital	Boston	Massachusetts
United States	PAB Clinical Research	Brandon	Florida
United States	Lowcountry Lung Critical Care	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Broward Research Group, Inc.	Hollywood	Florida
United States	Critical Care Pulmonary & Sleep Associates, LLC	Lakewood	Colorado
United States	Rowe Neurology Institute RNI - Lenexa	Lenexa	Kansas
United States	Advanced Neurodiagnostic Ceneter	Metairie	Louisiana
United States	EVMS Sleep Medicine	Norfolk	Virginia
United States	The Research Center of Southern California	Oceanside	California
United States	SDS Clinical Trials, INC	Orange	California
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	Center for Sleep & Circadian Neurobiology	Philadelphia	Pennsylvania
United States	UPMC Sleep Medicine Center	Pittsburgh	Pennsylvania
United States	Santa Monica Clinical Trials	Santa Monica	California
United States	Veritas Clinical Specialities LTD	Topeka	Kansas
United States	American Sleep Medicine	Vienna	Virginia
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Finland,  France,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient Global Impression of Change (PGIc)	Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. 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.	Week 4 to Week 6
Secondary	Clinical Global Impression of Change (CGIc)	Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.	Week 4 to Week 6
Secondary	Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)	Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities.	Week 4 to Week 6