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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
JZP-110
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sleep Disorder Center of Alabama
  • The Research Center of Southern California
  • SDS Clinical Trials, INC
  • Santa Monica Clinical Trials
  • Critical Care Pulmonary & Sleep Associates, LLC
  • PAB Clinical Research
  • Broward Research Group, Inc.
  • Oviedo Medical Research, LLC
  • Emory Sleep Center
  • Rowe Neurology Institute RNI - Lenexa
  • Veritas Clinical Specialities LTD
  • Advanced Neurodiagnostic Ceneter
  • Johns Hopkins Hospital
  • Brigham & Womens Hospital
  • Duke University Medical Center
  • PMG Research of Wilmington
  • Center for Sleep & Circadian Neurobiology
  • UPMC Sleep Medicine Center
  • Lowcountry Lung Critical Care
  • Medical University of South Carolina
  • EVMS Sleep Medicine
  • American Sleep Medicine
  • Tampere University Hospital
  • Turku University Hospital, Sleep Clinic
  • Helsinki Sleep Center
  • Grenoble University Hospital
  • CHU de Poitiers
  • Klinische Forschung Schwerin GmbH
  • Somnolab Dortmund
  • Department of Sleep Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

75, 150, 300 mg of JZP-110

Placebo

Arm Description

Once Daily Dosing

Once Daily Dosing

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 15, 2015
Last Updated
September 6, 2019
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02348619
Brief Title
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
75, 150, 300 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Intervention Type
Drug
Intervention Name(s)
JZP-110
Primary Outcome Measure Information:
Title
Change in the Maintenance of Wakefulness Test (MWT)
Description
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.
Time Frame
Week 4 to Week 6
Title
Change in the Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
Week 4 to Week 6
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIc)
Description
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.
Time Frame
Week 4 to Week 6
Title
Clinical Global Impression of Change (CGIc)
Description
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.
Time Frame
Week 4 to Week 6
Title
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Description
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.
Time Frame
Week 4 to Week 6

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: 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 Major Exclusion Criteria: 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
Facility Information:
Facility Name
Sleep Disorder Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
The Research Center of Southern California
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
SDS Clinical Trials, INC
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
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
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Broward Research Group, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Oviedo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Emory Sleep Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Rowe Neurology Institute RNI - Lenexa
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Veritas Clinical Specialities LTD
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Advanced Neurodiagnostic Ceneter
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Brigham & Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Center for Sleep & Circadian Neurobiology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Sleep Medicine Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lowcountry Lung Critical Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
EVMS Sleep Medicine
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
American Sleep Medicine
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Södra Finlands Län
ZIP/Postal Code
33200
Country
Finland
Facility Name
Turku University Hospital, Sleep Clinic
City
Turku
State/Province
Västra Finlands Län
ZIP/Postal Code
20520
Country
Finland
Facility Name
Helsinki Sleep Center
City
Helsinki
ZIP/Postal Code
00420
Country
Finland
Facility Name
Grenoble University Hospital
City
La Tronche
State/Province
Rhône-Alpes
ZIP/Postal Code
38700
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86000
Country
France
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
Somnolab Dortmund
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44263
Country
Germany
Facility Name
Department of Sleep Medicine
City
Gӧteborg
State/Province
Västra Götalands Län
ZIP/Postal Code
SE 413 45
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
30471270
Citation
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.
Results Reference
derived

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

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