Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Jazz Pharmaceuticals

Stanford Investigator(s):


  • Drug: JZP-110
  • Drug: Placebo oral tablet


Phase 3


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

   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

   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

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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Saba Mizra
Not Recruiting