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

Overview

About this study

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.

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:

  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

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

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

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CLS-20169963

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