A clinical trial to evaluate the effects of JZP-110 (study drug) on driving performance in subjects with excessive sleepiness due to Narcolpesy
- Conditions
- Treatment of excessive sleepiness in adult patients with narcolepsyMedDRA version: 20.0Level: HLTClassification code 10028716Term: Narcolepsy and associated conditionsSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-003931-36-NL
- Lead Sponsor
- Jazz Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
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 <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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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:<br><br>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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Endpoints:<br>• SDLP at 6 hr post-dose<br>• Proportion of subjects with improved or impaired driving on JZP-110 compared to placebo<br>• Standard deviation of Speed (SDS)<br>• Driving lapses<br>• PVT measures<br> - Inverse reaction time (1/RT)<br> - Lapses (RT>500 ms)<br> - Mean reaction time (RT)<br> - Errors of commission<br>• Toronto Hospital Alertness Test (THAT)<br>• Sleep, Activity, Fatigue and Task Effectiveness (SAFTE) modeling using PVT data will be generated.<br><br>;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.