NCT02806908CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)
Study Overview
Brief Summary
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, age 21 to 65 years inclusive
- •Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
- •BMI 18 to <40 kg/m2
- •Willing and able to provide written informed consent
Exclusion Criteria
- •Female subjects who are pregnant, nursing, or lactating
- •Moderate or severe sleep apnea
- •Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- •History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- •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
- •History of bariatric surgery within the past year or a history of any gastric bypass procedure
- •Presence or history of significant cardiovascular disease
- •Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
Arms & Interventions
Placebo
Placebo Comparator
Once daily dosing
Intervention: Placebo (Drug)
JZP-110
Active Comparator
150 mg/day for first 3 days and 300 mg/day for next 4 days
Intervention: JZP-110 (Drug)
Outcomes
Primary Outcomes
Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)
Time Frame: 2 hours post-dose
Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr). Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded. Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
Secondary Outcomes
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Standard Deviation of Speed (SDS) at 2 Hours Post-dose(2 hours post-dose)
- SDS at 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- PVT Number of Lapses at 6 Hours Post-dose(6 hours post-dose)
- SDLP at 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1 Centimeter (cm) on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Number of Lapses in Driving Test at 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- PVT Mean Reaction Time at 2 Hours Post-dose(2 hours post-dose)
- PVT Mean Reaction Time at 6 Hours Post-dose(6 hours post-dose)
- PVT Inverse Reaction Time at 2 Hours Post-dose(2 hours post-dose)
- PVT Inverse Reaction Time at 6 Hours Post-dose(6 hours post-dose)
- PVT Number of Errors of Commission at 2 Hours Post-dose(2 hours post-dose)
- PVT Number of Errors of Commission at 6 Hours Post-dose(6 hours post-dose)
- Toronto Hospital Alert Test (THAT)(Post Treatment at day 21)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Lapses in Driving Test at 2 Hours Post-dose(2 hours post-dose)
- Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose(2 hours post-dose)
Investigators
Study Sites (1)
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