A clinical trial to evaluate the effects of JZP-110 (study drug) on driving performance in subjects with excessive sleepiness due to Obstructive Sleep Apnea

Phase 1

• Conditions: Treatment of excessive sleepiness in adult patients with obstructive sleep apnea; to increase the ability to stay awake throughout the day.; MedDRA version: 20.0Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndromeSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003930-28-DE
• Lead Sponsor: Jazz Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-15
• Study Completion: 2019-05-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Inclusion:
1. Male or female, age 21 to 75 years inclusive
2. Diagnosis of obstructive sleep apnea (OSA) per ICSD-3
3. BMI 18 to <40 kg/m2
4. Use a medically acceptable method of contraception
5. Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion:
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 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 and/or safety assessments per the judgment of the investigator
5. History of bariatric surgery within the past year
6. Presence of significant cardiovascular disease
7. Use of any over-the-counter (OTC) or prescription medications that could affect sleep-wake function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified