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.