Phase 3
Completed N=236
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Source: ClinicalTrials.gov NCT02348593 ↗Enrolled (actual)
236
Serious AEs
0.4%
Results posted
Jul 2019
Primary outcomePrimary: Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 — 2.12; 4.74; 9.77; 12.27 minutes
◆ Published Evidence
Highly cited
192citations · ~32 / year
Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy.
Summary
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
Linked Publications (4)
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Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy.
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Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial.
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Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.
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Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 |
2.12; 4.74; 9.77; 12.27 | — |
| PRIMARY Change in ESS Score From Baseline to Week 12 |
-1.6; -3.8; -5.4; -6.4 | — |
| SECONDARY Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 |
39.7; 67.8; 78.2; 84.7 | — |
| SECONDARY Change in Sleep Latency Time on MWT Trial 1 at Week 12 |
-0.55; 3.27; 9.87; 9.91 | — |
| SECONDARY Change in Sleep Latency Time on MWT Trial 2 at Week 12 |
1.41; 5.70; 9.46; 14.50 | — |
| SECONDARY Change in Sleep Latency Time on MWT Trial 3 at Week 12 |
3.79; 6.35; 11.31; 13.99 | — |
| SECONDARY Change in Sleep Latency Time on MWT Trial 4 at Week 12 |
2.33; 3.77; 9.77; 13.50 | — |
| SECONDARY Change in Sleep Latency Time on MWT Trial 5 at Week 12 |
3.09; 3.92; 9.25; 12.20 | — |
| SECONDARY Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4 |
2.16; 4.67; 9.15; 13.07 | — |
Eligibility Criteria
Major Inclusion Criteria:
- Males and females between 18 and 75 years of age, inclusive
- Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
- Body mass index from 18 to <45 kg/m2
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Major Exclusion Criteria:
- Female subjects who are pregnant, nursing, or lactating
- Moderate or severe sleep apnea on the baseline PSG.
- 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 acutely 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
- History of bariatric surgery within the past year or a history of any gastic bypass procedure
- Presence or history of significant cardiovascular disease
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Use of any medications that could affect the evaluation of cataplexy
- Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Data sourced from ClinicalTrials.gov (NCT02348593) and the linked publication. 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. Informational only — not medical advice.