0621 Measures of Function, Work Productivity, and Quality of Life From a Phase 3 Study of Solriamfetol (JZP-110) in Patients with Narcolepsy
Bibliographic record
Abstract
Solriamfetol is a selective dopamine/norepinephrine reuptake inhibitor with wake-promoting effects. In a phase 3 study, solriamfetol significantly improved wakefulness and decreased excessive sleepiness in adults with narcolepsy. Health-related quality of life (HRQoL) measures were secondary endpoints. Participants with narcolepsy were randomized to solriamfetol 75mg, 150mg, or 300mg, or placebo for 12 weeks. Secondary measures included the Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), Work Productivity and Activity Impairment questionnaire for Specific Health Problems (WPAI:SHP), and 36-Item Short Form Health Survey version 2 (SF-36v2). Least squares mean (standard error) (LS mean [SE]) change from baseline to week 12 was calculated with significance set at P<0.05. Safety and tolerability were also assessed. Baseline demographics were similar across treatment groups. Solriamfetol 300mg significantly improved the FOSQ-10 score (LS mean [SE]: 300mg, 3.01 [0.42]; placebo, 1.56 [0.40]; P<0.05). Solriamfetol significantly reduced percent overall work impairment on the WPAI at 150mg (LS mean [SE]: 150mg, -19.77 [5.04]; placebo, -4.28 [5.00]; P<0.05) and reduced percent activity impairment at 150 and 300mg (LS mean [SE]: 300mg, -21.27 [3.55]; 150mg, -17.84 [3.35]; placebo, -7.79 [3.42]; P<0.05). Significant improvements in SF-36v2 domains were seen for role physical score (LS mean [SE]: 300mg, 6.46 [1.21]; placebo, 2.38 [1.14]; P<0.05), general health (LS mean [SE]: 75mg, 2.42 [0.84]; placebo, -0.20 [0.81]; P<0.05), and vitality score (LS mean [SE]: 300mg, 4.96 [1.19]; 150mg, 5.83 [1.12]; 75mg, 4.68 [1.15]; placebo, 1.04 [1.12]; P<0.05). The most common treatment-emergent adverse events were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety. Solriamfetol improved functioning, and HRQoL, at 300mg, particularly on the vitality (all doses) and role physical domains. HRQoL domains such as emotional and social functioning were not affected. Impairment at work was improved at 150mg, whereas activity impairment outside of work was improved at 150 and 300mg. Safety and tolerability were consistent with previous solriamfetol studies. Jazz Pharmaceuticals.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".