0619 Solriamfetol (JZP-110) for Treatment of Excessive Sleepiness in Narcoleptic Patients With and Without Cataplexy: Results From a Randomized, Phase 3, Clinical Trial
Bibliographic record
Abstract
Efficacy and safety from a positive phase 3 trial of solriamfetol in patients with narcolepsy were further evaluated by cataplexy status. Patients with narcolepsy received solriamfetol 75mg, 150mg, 300mg, or placebo for 12 weeks and were stratified by those with cataplexy (NWC; n=117) and without cataplexy (NWOC; n=114). Endpoints included change from baseline at week 12 on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS), and Patient Global Impression of Change (PGI-C) scale. Safety was evaluated in both subgroups. At baseline, NWC and NWOC patients had similar MWT mean sleep latencies (mean±SD: 6.6 ± 5.8 and 8.5 ± 5.7 minutes, respectively) and ESS scores (17.8 ± 3.2 and 16.5 ± 3.0, respectively). Least squares mean differences from placebo (95% confidence interval) for change from baseline at week 12 on MWT in the NWC group were 1.6 (-3.6, 6.9), 6.1 (0.7, 11.4) and 8.9 (3.5, 14.2) minutes for solriamfetol 75mg, 150mg, and 300mg, respectively; for NWOC these were 3.4 (-1.9, 8.7), 9.1 (3.8, 14.3), and 11.2 (5.8, 16.6) minutes for the solriamfetol doses, respectively. On the ESS, the least squares mean differences from placebo (95% confidence interval) for change from baseline at week 12 were -1.3 (-3.9, 1.3), -3.7 (-6.4, -1.1), and -4.5 (-7.1, -1.9) for solriamfetol 75mg, 150mg, and 300mg, respectively in the NWC group, and -3.0 (-5.6, -0.4), -3.7 (-6.3, -1.2), -4.9 (-7.6, -2.2) for these doses, respectively, in the NWOC group. At week 12, a higher percentage of solriamfetol-treated patients reported improvement on the PGI-C relative to placebo. The most common treatment-emergent adverse events were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety, and these were similar between the two subgroups. Solriamfetol was effective in treating excessive sleepiness in patients with narcolepsy with or without cataplexy as demonstrated by the robust effects on MWT, ESS, and PGI-C, regardless of cataplexy status. The safety profile was similar in NWC and NWOC patients and was consistent with previous solriamfetol studies. 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 | 0.004 |
| 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 | 0.000 | 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".