PMID- 27166238
OWN - NLM
STAT- MEDLINE
DCOM- 20171013
LR  - 20191217
IS  - 1550-9109 (Electronic)
IS  - 0161-8105 (Print)
IS  - 0161-8105 (Linking)
VI  - 39
IP  - 7
DP  - 2016 Jul 1
TI  - Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with 
      Narcolepsy: A Phase 2b Study.
PG  - 1379-87
LID - 10.5665/sleep.5968 [doi]
AB  - STUDY OBJECTIVES: To evaluate the efficacy and safety of oral JZP-110, a 
      second-generation wake-promoting agent with dopaminergic and noradrenergic 
      activity, for treatment of impaired wakefulness and excessive sleepiness in 
      adults with narcolepsy. METHODS: This was a phase 2b, randomized, double-blind, 
      placebo-controlled, parallel-group trial conducted at 28 centers in the United 
      States. Patients were adults with narcolepsy who had baseline scores >/= 10 on the 
      Epworth Sleepiness Scale (ESS) and baseline sleep latency </= 10 min on the 
      Maintenance of Wakefulness Test (MWT). Patients received a daily placebo (n = 49) 
      or JZP-110 (n = 44) 150 mg/day weeks 1-4 and 300 mg/day weeks 5-12. Primary 
      efficacy endpoints were change from baseline in average MWT sleep latency, and 
      the Clinical Global Impression-Change (CGI-C); secondary endpoints were change 
      from baseline in ESS score and Patient Global Impression-Change. RESULTS: 
      Improvements were significantly greater with JZP-110 versus placebo on mean MWT 
      sleep latency (4 w, 9.5 versus 1.4 min, P < 0.0001; 12 w, 12.8 versus 2.1 min, P 
      < 0.0001), percentage of patients with CGI-C improvement (4 w, 80% versus 51%, P 
      = 0.0066; 12 w, 86% versus 38%, P < 0.0001), and mean change in ESS (4 w, -5.6 
      versus -2.4, P = 0.0038; 12 w, -8.5 versus -2.5, P < 0.0001). Three 
      JZP-110-treated patients (6.8%) discontinued due to adverse events (AEs). The 
      most common AEs with JZP-110 versus placebo were insomnia (23% versus 8%), 
      headache (16% versus 10%), nausea (14% versus 6%), diarrhea (11% versus 6%), 
      decreased appetite (14% versus 0%), and anxiety (11% versus 0%). CONCLUSIONS: At 
      doses of 150-300 mg/day, JZP-110 was well tolerated and significantly improved 
      the ability to stay awake and subjective symptoms of excessive sleepiness in 
      adults with narcolepsy. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov 
      identifier NCT01681121.
CI  - (c) 2016 Associated Professional Sleep Societies, LLC.
FAU - Ruoff, Chad
AU  - Ruoff C
AD  - Stanford University Sleep Medicine Center, Redwood City, CA.
FAU - Swick, Todd J
AU  - Swick TJ
AD  - Neurology and Sleep Medicine Consultants of Houston, University of Texas-Houston 
      School of Medicine, Houston, TX.
FAU - Doekel, Robert
AU  - Doekel R
AD  - Sleep Disorders Center of Alabama, Birmingham, AL.
FAU - Emsellem, Helene A
AU  - Emsellem HA
AD  - The Center for Sleep & Wake Disorders, Chevy Chase, MD.
FAU - Feldman, Neil T
AU  - Feldman NT
AD  - St Petersburg Sleep Disorders Center at Palms of Pasadena Hospital, St 
      Petersburg, FL.
FAU - Rosenberg, Russell
AU  - Rosenberg R
AD  - NeuroTrials Research, Atlanta, GA.
FAU - Bream, Gary
AU  - Bream G
AD  - Aerial BioPharma, Morrisville, NC.
FAU - Khayrallah, Moise A
AU  - Khayrallah MA
AD  - Aerial BioPharma, Morrisville, NC.
FAU - Lu, Yuan
AU  - Lu Y
AD  - Jazz Pharmaceuticals, Inc., Palo Alto, CA.
FAU - Black, Jed
AU  - Black J
AD  - Stanford University Sleep Medicine Center, Redwood City, CA.
AD  - Jazz Pharmaceuticals, Inc., Palo Alto, CA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01681121
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160701
PL  - United States
TA  - Sleep
JT  - Sleep
JID - 7809084
RN  - 0 (Carbamates)
RN  - 0 (Wakefulness-Promoting Agents)
RN  - 47E5O17Y3R (Phenylalanine)
RN  - 939U7C91AI (solriamfetol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Carbamates/pharmacology/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Narcolepsy/*drug therapy/physiopathology
MH  - Phenylalanine/*analogs & derivatives/pharmacology/therapeutic use
MH  - Sleep Stages/drug effects
MH  - Treatment Outcome
MH  - Wakefulness/drug effects
MH  - Wakefulness-Promoting Agents/pharmacology/*therapeutic use
PMC - PMC4909620
OTO - NOTNLM
OT  - *JZP-110
OT  - *excessive sleepiness
OT  - *narcolepsy
OT  - *wakefulness
EDAT- 2016/05/12 06:00
MHDA- 2017/10/14 06:00
PMCR- 2017/01/01
CRDT- 2016/05/12 06:00
PHST- 2015/12/10 00:00 [received]
PHST- 2016/03/19 00:00 [accepted]
PHST- 2016/05/12 06:00 [entrez]
PHST- 2016/05/12 06:00 [pubmed]
PHST- 2017/10/14 06:00 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - sp-00708-15 [pii]
AID - 10.5665/sleep.5968 [doi]
PST - epublish
SO  - Sleep. 2016 Jul 1;39(7):1379-87. doi: 10.5665/sleep.5968.