Clinical trial NCT02806908: Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Excessive Sleepiness
Keywords: Driving
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age 21 to 65 years inclusive
2. Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
3. BMI 18 to \<40 kg/m2
4. Willing and able to provide written informed consent

Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating
2. Moderate or severe sleep apnea
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. 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
6. History of bariatric surgery within the past year or a history of any gastric bypass procedure
7. Presence or history of significant cardiovascular disease
8. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: SDLP at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 1 Centimeter (cm) on JZP-110 Compared to Placebo 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 1 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Standard Deviation of Speed (SDS) at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: SDS at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Number of Lapses in Driving Test at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Lapses in Driving Test at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: PVT Number of Lapses at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: PVT Mean Reaction Time at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: PVT Mean Reaction Time at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: PVT Inverse Reaction Time at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: PVT Inverse Reaction Time at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: PVT Number of Errors of Commission at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: PVT Number of Errors of Commission at 6 Hours Post-dose
timeFrame: 6 hours post-dose
measure: Toronto Hospital Alert Test (THAT)
timeFrame: Post Treatment at day 21
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Jazz Pharmaceuticals
name: Grace Wang, MD
role: STUDY_DIRECTOR
affiliation: Maastricht University
name: Jan Ramaekers, PhD
role: PRINCIPAL_INVESTIGATOR
References: