0675 A RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3 STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH NARCOLEPSY
Bibliographic record
Abstract
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. In two phase 2 clinical studies in patients with narcolepsy type 1 and 2 (NT1/2), JZP-110 significantly improved wakefulness and reduced excessive sleepiness (ES). This phase 3 study is designed to further understand the safety and efficacy of JZP-110 in NT1/2. Key eligibility criteria included: diagnosis of NT1/2 according to International Classification of Sleep Disorders-3 criteria; mean sleep latency ≤25 minutes on first 4 trials of a 5-trial, 40-minute Maintenance of Wakefulness Test (MWT); Epworth Sleepiness Scale (ESS) score ≥10; usual nightly sleep time ≥6 hours. Key exclusion criteria were: use of medications that could affect ES or cataplexy; night-time or variable shift work; conditions other than narcolepsy that cause ES. Patients were randomized (1:1:1:1) to receive JZP-110 75mg, 150mg, or 300mg, or placebo for 12 weeks and were stratified by NT1/2 phenotype. Co-primary endpoints were change from baseline to week 12 in MWT mean sleep latency and ESS score. The percentage of patients reporting improvement on the Patient Global Impression of Change (PGI-C) was the key secondary endpoint; cataplexy was an exploratory endpoint. Safety evaluation included adverse events, laboratory tests, and vital signs. Complete enrollment occurred in November 2016. Preliminary demographics from 175 of the 240 randomized patients show the population was 66.9% female, 78.3% white, with mean±standard deviation age 37.1 ± 13.7 years. Baseline ESS score and MWT were 17.2 ± 3.3 and 6.2 ± 4.8 minutes, respectively, and 96.0% of patients were ≥moderately ill on Clinical Global Impression of Severity. All patients have completed participation in the study; full efficacy and safety results will be reported. This large randomized, placebo-controlled phase 3 study provides pivotal data on efficacy and safety of JZP-110 for treatment of ES with narcolepsy. Jazz Pharmaceuticals.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".