Methods:
This double-blind, placebo-controlled, parallel-
group, multicenter study evaluated safety and efficacy of
N05over 12weeks in subjects aged 18-70 yearswith an
ICSD-2diagnosis of narcolepsy. Subjectswere randomized
toonce-daily placebo (n=49) or N05 (n=44). Doses of N05
were150mg/dayweeks 1-4 and 300mg/dayweeks 5-12.
Co-primary efficacy endpointswere change from baseline
to last assessment in average sleeponset latency (SOL) on
theMaintenanceofWakefulnessTest (MWT) andClinical
Global Impression-Change (CGIC). Secondary endpoints
included change from baseline at weeks 4 and 12on the
EpworthSleepinessScale (ESS).
Results:
Week 4 changes from baselinewere significantly
greater withN05 150mg relative to placebo: increased
MWTSOL (9.5minutes vs 1.4minutes;
P
<0.0001), CGIC
improvement (80% vs 51%;
P
=0.0066) anddecreased
ESS scores (5.6 points vs 2.4 points;
P
=0.0038).At week
12, following 8weeks of 300mg, N05 resulted in greater
improvement from baseline than placebo onMWTSOL
(12.8minutes vs 2.1minutes;
P<
0
.
0001), ESS (8.5 points
vs 2.5points;
P
<0.0001), and proportion of patientswith
CGIC improvement (86% vs 38%;
P
<0.0001). Three
subjects (6.8%) in theN05 group discontinued due to
adverse events (AEs). Themost commonAEswithN05
vs placebowere headache (16% vs 10%), nausea (14%
vs 6%), diarrhea (11% vs 6%), insomnia (14% vs 2%),
decreased appetite (14% vs 0%) andanxiety (11% vs 0%).
Two seriousAEs (conversiondisorder, acute cholecystitis)
in theN05 groupwere considered probably unrelated to
N05.
Conclusion:
At doses of 150-300mg/day, N05was
well-toleratedand significantly improved objective and
subjective symptoms of EDS in adultswith narcolepsy.
Support:
This studywas supported byAerial BioPharma.
Speeding narcolepsy
diagnosis through
greater awareness
Supporting research
for a cure
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to learnmore
“Peoplewith narcolepsy have
been living in the shadows.
It’s time to step into the light.”
– Kevin J. Cosgrove, Co-founder
LateBreakingAbstracts
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