SEATTLE, WA—Clinician- and patient-reported assessments of global impression of change in disease status had “good concordance” for narcolepsy treated with JZP-110, a novel wake-promoting agent, according to results of a post hoc analysis reported at SLEEP 2015.
These findings were indicated by a strong and statistically significant positive correlation between the Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C) scales scores, noted Lawrence Scrima, PhD, of the Sleep-Alertness Disorders Center, Inc, in Aurora, CO.
Previously, a 12-week Phase 2b trial of JPZ-110 found the agent improved objective and subjective symptoms of excessive sleepiness in adults with narcolepsy.
“This post hoc analysis evaluated the correlation between the patient and clinician perspectives for overall change in disease status,” said Dr. Scrima. The mechanism of action of JZP-110 appears to be distinct from modafinil and traditional stimulants used in patients with excessive daytime sleepiness associated with narcolepsy, he said.
The double-blind, placebo-controlled, parallel-group study randomized adults with an ICSD-2 diagnosis of narcolepsy 12 weeks of treatment with once-daily placebo (n=49) or JZP-110 at a dose of 150mg/day for Weeks 1–4 that was increased to 300mg/day for Weeks 5–12 (n=44).
Change in disease status from baseline was assessed at 1, 2, 4, 6, 8, and 12 weeks using the CGI-C and PGI-C scales, both of which are scored using a 7-point Likert-type scale, with 1 being “very much improved” and 7 being “very much worse.” Baseline characteristics were similar between the two groups. A total of 90 patients were evaluable for response.
At Week 12, significantly more patients in the JZP-110 arm showed improvement on the CGI-C (86.0% vs 38.3%; P<0.0001) and PGI-C (93.0% vs 38.3%; P<0.0001) compared with placebo, Dr. Scrima reported.
A large percentage of PGI-C scores, 74.4%, matched the CGI-C scores. The correlation between the PGI-C and CGI-C scores was strong and statistically significant (Spearman r = 0.868; P<0.0001), he concluded.