Clinical Trial: A Study to Assess the Wakefulness Promoting Effect, Safety, Tolerability, and Pharmacokinetics (PK) of LML134 in Shift Work Disorder

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized, Subject and Investigator-blinded, Placebo Controlled, Cross-over, Multi-center Proof of Concept (PoC) Study to Assess the Wakefulness Promoting Effect, Safety, Tolerability, and PK of LM

Brief Summary:

The main purpose of this study is to demonstrate that LML134 can increase wakefulness compared to placebo in patients with shift work disorder (SWD) measured by objective and subjective endpoints of wakefulness, i.e. the sleep latency in the multiple sleep latency test (MSLT) and the Karolinska Sleepiness Scale (KSS), respectively. Safety and PK of LML134 will also be evaluated. In addition, novel methodologies to measure wakefulness and sleep will also be tested and compared to gold standard methods like the MSLT and polysomnography (PSG). The aim of such comparisons is to evaluate the usefulness of the new technologies in clinical studies and provide preliminary validation data.

This is a randomized, subject and investigator-blinded, placebo controlled, crossover, multi-center Proof of Concept (PoC) study with in-house simulated laboratory night shifts in patients with SWD. This non-confirmatory study will include two treatment arms: LML134 and placebo. After a screening period, the treatment phase of the study will consist of two overnight stays in a sleep lab in each of two treatment periods, with a minimum one week wash-out in between.


Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Average sleep latency in MSLT [ Time Frame: 2 days (up to 8 hours each) ]

Average sleep latency over two consecutive test nights as measured by the MSLT (total of 8 assessments)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sleep latency in MSLT at separate naps [ Time Frame: 2 days (up to 8 hours each) ]
    MSLT at each time point averaged over two consecutive test nights (4 separate values corresponding to the 4 testing time points on each night)
  • Pharmacokinetic Cmax [ Time Frame: 3 weeks ]
    Maximum plasma concentration
  • Pharmacokinetic T1/2 [ Time Frame: 3 weeks ]
    Plasma half-life
  • Polysomnography total time [ Time Frame: 2 days (8 hours each) ]
    Total time in bed
  • Polysomnography sleep time [ Time Frame: 2 days (8 hours each) ]
    Total sleep time
  • Polysomnography efficiency [ Time Frame: 2 days (8 hours each) ]
    Sleep efficiency
  • Polysomnography wake [ Time Frame: 2 days (8 hours each) ]
    Wake after sleep onset
  • Polysomnography latency [ Time Frame: 2 days (8 hours each) ]
    Sleep onset latency
  • Polysomnography awakenings [ Time Frame: 2 days (8 hours each) ]
    Number of awakenings
  • Polysomnography REM [ Time Frame: 2 days (8 hours each) ]
    Sleep latency to REM sleep
  • Polysomnography cycles [ Time Frame: 2 days (8 hours each) ]
    Number of sleep cycles
  • Polysomnography stages [ Time Frame: 2 days (8 hours each) ]
    Percentage of time spent in each sleep stage


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: April 28, 2017
Date Started: May 30, 2017
Date Completion: December 6, 2017
Last Updated: May 3, 2017
Last Verified: May 2017