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

Jazz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Obstructive Sleep Apnea

Treatments: Drug: JZP-110; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02348606

14-003

Details and patient eligibility

About

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.

Enrollment: 476 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major 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

Major 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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476 participants in 5 patient groups

37.5 mg of JZP-110

Active Comparator group

Description:

Once Daily Dosing

Treatment:

Drug: JZP-110

75 mg of JZP-110

Active Comparator group

Description:

Once Daily Dosing

Treatment:

Drug: JZP-110

150 mg of JZP-110

Active Comparator group

Description:

Once Daily Dosing

Treatment:

Drug: JZP-110

300 mg of JZP-110

Active Comparator group

Description:

Once Daily Dosing

Treatment:

Drug: JZP-110

Placebo

Active Comparator group

Description:

Once Daily Dosing

Treatment:

Drug: Placebo oral tablet