SEATTLE — 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.

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“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.

This article originally appeared on MPR