A Study of the Safety and Effectiveness of JZP-110 in the Treatment of Excessive Sleepiness in Patients with Narcolepsy

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Males and females
  • Between 18 and 75 years of age, inclusive
  • Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
  • Body mass index from 18 to < 40 kg/m2
  • Consent to use a medically acceptable method of contraception
  • Willing and able to provide written informed consent

Exclusion Criteria

  • Female subjects who are pregnant, nursing, or lactating
  • Moderate or severe sleep apnea on the baseline PSG
  • Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator 
  • History of bariatric surgery within the past year
  • Presence or history of cardiovascular disease 
  • Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
  • Use of any medications that could affect the evaluation of cataplexy 
  • Received an investigational drug in the past 30 days or five half-lives (whichever is longer) 
  • Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A) 
  • History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lois Krahn, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20197250

Mayo Clinic Footer