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

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ClinicalTrials.gov Identifier: NCT02348606
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Brief Summary:
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: JZP-110 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, 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 Start Date : May 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: 37.5 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 75 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 150 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 300 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: Placebo
Once Daily Dosing
Drug: JZP-110



Primary Outcome Measures :
  1. Maintenance of Wakefulness Test (MWT): Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 12 [ Time Frame: 12 Weeks ]
  2. Epworth Sleepiness Scale (ESS): Change in ESS score from Baseline to Week 12 [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Patient Global Impression of change: Percentage of subjects reported as improved (minimally, much, or very much) at Week 12 [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348606


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Sponsors and Collaborators
Jazz Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02348606     History of Changes
Other Study ID Numbers: 14-003
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases