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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02348632
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea
Study Start Date : May 2015
Primary Completion Date : December 2017
Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
75 mg - 300 mg of JZP-110
Once Daily Dosing
Drug: JZP-110

Primary Outcome Measures :
  1. The number and percent of subjects who experienced treatment emergent adverse events. [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  1. Changes in Epworth Sleepiness Scale scores, Patient Global Impression of Change ratings, and Clinical Global Impression of Change ratings. [ Time Frame: 52 Weeks ]

Information from the National Library of Medicine

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

Major Inclusion Criteria:

  1. Subject meets one of the following:

    1. Completed Study 14-002 or 14-003 (Group A)
    2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
  2. Body mass index from 18 to <45 kg/m2
  3. Consent to use a medically acceptable method of contraception
  4. 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 narcolepsy or 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. 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
  5. History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
  9. 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 identifier (NCT number): NCT02348632

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Sponsors and Collaborators
Jazz Pharmaceuticals

Responsible Party: Jazz Pharmaceuticals Identifier: NCT02348632     History of Changes
Other Study ID Numbers: 14-005
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Disorders of Excessive Somnolence
Mental Disorders