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

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 - Narcolepsy Driving Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003931-36-NL

Enrollment

Registered

2016-01-18

Start date

2016-05-02

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of excessive sleepiness in adult patients with narcolepsy MedDRA version: 20.0 Level: HLT Classification code 10028716 Term: Narcolepsy and associated conditions System Organ Class: 100000004873

Interventions

Product Name: (R)-2-amino-3-phenylpropylcarbamate hydrochloride Product Code: JZP110 Pharmaceutical Form: Capsule INN or Proposed INN: Solriamfetol CAS Number: 178429-65-7 Current Sponsor code: JZP-11

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion: 1. Male or female, age 21 to 75 years inclusive 2. Diagnosis of narcolepsy per ICSD-3 or DSM-5 3. BMI 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Exclusion: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the effect of JZP-110 on driving performance;Secondary Objective: 1. To evaluate the safety and tolerability of JZP-110 2. To explore SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) modeling using driving, Psychomotor Vigilance Test (PVT) and sleep data;Primary end point(s): Primary Efficacy Endpoint: Standard deviation of lateral position (SDLP) at 2 hours post-dose;Timepoint(s) of evaluation of this end point: Subjects will receive JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in Period 1, and crossover to receive the other treatment for 7 days in Period 2.	—

Measure

Time frame

Main Objective: 1. To evaluate the effect of JZP-110 on driving performance;Secondary Objective: 1. To evaluate the safety and tolerability of JZP-110 2. To explore SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) modeling using driving, Psychomotor Vigilance Test (PVT) and sleep data;Primary end point(s): Primary Efficacy Endpoint: Standard deviation of lateral position (SDLP) at 2 hours post-dose;Timepoint(s) of evaluation of this end point: Subjects will receive JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in Period 1, and crossover to receive the other treatment for 7 days in Period 2.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Efficacy Endpoints: • SDLP at 6 hr post-dose • Proportion of subjects with improved or impaired driving on JZP-110 compared to placebo • Standard deviation of Speed (SDS) • Driving lapses • PVT measures - Inverse reaction time (1/RT) - Lapses (RT>500 ms) - Mean reaction time (RT) - Errors of commission • Toronto Hospital Alertness Test (THAT) • Sleep, Activity, Fatigue and Task Effectiveness (SAFTE) modeling using PVT data will be generated. ;Timepoint(s) of evaluation of this end point: Subjects will receive JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in Period 1, and crossover to receive the other treatment for 7 days in Period 2.	—

Measure

Time frame

Secondary end point(s): Secondary Efficacy Endpoints: • SDLP at 6 hr post-dose • Proportion of subjects with improved or impaired driving on JZP-110 compared to placebo • Standard deviation of Speed (SDS) • Driving lapses • PVT measures - Inverse reaction time (1/RT) - Lapses (RT>500 ms) - Mean reaction time (RT) - Errors of commission • Toronto Hospital Alertness Test (THAT) • Sleep, Activity, Fatigue and Task Effectiveness (SAFTE) modeling using PVT data will be generated. ;Timepoint(s) of evaluation of this end point: Subjects will receive JZP-110 (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or the matching placebo for 7 days in Period 1, and crossover to receive the other treatment for 7 days in Period 2.

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Countries

Germany, Netherlands

Contacts

Public ContactGrace Wang

Jazz Pharmaceuticals Inc.

grace.wang@jazzpharma.com001650496 2687

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 18, 2026