Phase 2
N=24
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Narcolepsy · Excessive Sleepiness
Bottom Line
View on ClinicalTrials.gov: NCT02806908 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax) — 20.46; 19.08 centimeter (cm) — p=0.0022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JZP-110 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax) |
20.46; 19.08 | 0.0022 sig |
| SECONDARY SDLP at 6 Hours Post-dose |
19.78; 19.59 | 0.0416 sig |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 1 Centimeter (cm) on JZP-110 Compared to Placebo 2 Hours Post-dose |
5; 5 | 0.0963 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose |
10; 5 | 0.3018 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose |
9; 5 | 0.4240 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose |
6; 4 | 0.7539 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose |
6; 4 | 0.7539 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose |
4; 4 | 1.0000 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 1 cm on JZP-110 Compared to Placebo 6 Hours Post-dose |
10; 7 | 0.6291 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose |
8; 7 | 1.0000 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose |
8; 7 | 1.0000 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose |
8; 7 | 1.0000 |
| SECONDARY Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose |
7; 5 | 0.7744 |
| SECONDARY 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; 6 | 0.7539 |
| SECONDARY Standard Deviation of Speed (SDS) at 2 Hours Post-dose |
2.97; 2.76 | 0.1141 |
| SECONDARY SDS at 6 Hours Post-dose |
3.18; 3.08 | 0.4441 |
| SECONDARY Number of Lapses in Driving Test at 2 Hours Post-dose |
3.26; 2.27 | 0.3423 |
| SECONDARY Number of Lapses in Driving Test at 6 Hours Post-dose |
3.72; 3.64 | 0.9384 |
| SECONDARY Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose |
7.47; 3.04 | 0.0939 |
| SECONDARY PVT Number of Lapses at 6 Hours Post-dose |
9.88; 3.81 | 0.0246 sig |
| SECONDARY PVT Mean Reaction Time at 2 Hours Post-dose |
633.30; 311.74 | 0.1475 |
| SECONDARY PVT Mean Reaction Time at 6 Hours Post-dose |
628.26; 309.81 | 0.1513 |
| SECONDARY PVT Inverse Reaction Time at 2 Hours Post-dose |
3.36; 3.82 | 0.0002 sig |
| SECONDARY PVT Inverse Reaction Time at 6 Hours Post-dose |
3.34; 3.77 | 0.0005 sig |
| SECONDARY PVT Number of Errors of Commission at 2 Hours Post-dose |
1.65; 1.26 | 0.4774 |
| SECONDARY PVT Number of Errors of Commission at 6 Hours Post-dose |
1.92; 1.45 | 0.3801 |
| SECONDARY Toronto Hospital Alert Test (THAT) |
26.83; 33.97 | <0.0001 sig |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02806908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.