A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Narcolepsy

Phase 2

Completed

• Conditions: Narcolepsy; sleep disease; 10040998

• Registration Number: NL-OMON47913
• Lead Sponsor: JAZZ Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1. Male or female, age 21 to 75 years inclusive
2. Diagnosis of narcolepsy per ICSD-3 or DSM-5
3. BMI 18 to <40 kg/m2
4. 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 narcolepsy 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 or a history of any
gastric bypass procedure
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Standard deviation of lateral position (SDLP) at 2 hours post-dose<br /><br>(approximately at Tmax)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* SDLP at 6 hr post-dose<br /><br>* Proportion of subjects with improved or impaired driving on JZP-110 compared<br /><br>to placebo<br /><br>* Standard deviation of Speed (SDS)<br /><br>* Driving lapses<br /><br>* PVT measures<br /><br>* Inverse reaction time (1/RT)<br /><br>* Lapses (RT>500 ms)<br /><br>* Mean reaction time (RT)<br /><br>* Errors of commission<br /><br>* Toronto Hospital Alertness Test (THAT)</p><br>