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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02348593
First received: January 15, 2015
Last updated: November 30, 2016
Last verified: September 2016
  Purpose
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

Condition Intervention Phase
Narcolepsy Drug: JZP-110 Phase 3

Study Type: Interventional
Study Design: 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 Narcolepsy

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]
  • Epworth Sleepiness Scale (ESS): Change in ESS score from Baseline to Week 12 [ Time Frame: 12 Weeks ]

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

Enrollment: 240
Study Start Date: May 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 75 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 150 mg JZP-110
Once Daily Dosing
Drug: JZP-110
Active Comparator: 300 mg of JZP-110
Once Daily Dosing
Drug: JZP-110
Placebo Comparator: Placebo
Once Daily Dosing
Drug: JZP-110

  Eligibility

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

Major Inclusion Criteria:

  1. Males and females between 18 and 75 years of age, inclusive
  2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 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. Moderate or severe sleep apnea on the baseline PSG.
  3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
  4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  5. 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
  6. History of bariatric surgery within the past year or a history of any gastic bypass procedure
  7. Presence or history of significant cardiovascular disease
  8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
  9. Use of any medications that could affect the evaluation of cataplexy
  10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
  11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
  12. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02348593

  Show 60 Study Locations
Sponsors and Collaborators
Jazz Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02348593     History of Changes
Other Study ID Numbers: 14-002
Study First Received: January 15, 2015
Last Updated: November 30, 2016

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017