Clinical Trials Logo
  1. Home
  2. Circadian Rhythm Disorders
  3. NCT03141086

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

Circadian Rhythm Disorders Clinical Trial

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 LML134 in Shift Work Disorder (SWD) Patients

Clinical Trial Summary

The main purpose of this study was 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 were also evaluated. In addition, novel methodologies to measure wakefulness and sleep were also to be tested and compared to gold standard methods like the MSLT and polysomnography (PSG) (at sites where staff have appropriate equipment and training). The aim of such comparisons was to evaluate the usefulness of the new technologies in clinical studies and provide preliminary validation data. This was 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 included two treatment arms: LML134 and placebo. After a screening period, the treatment phase of the study consisted of two overnight stays in a sleep lab in each of two treatment periods, with a minimum one week wash-out in between.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03141086
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 2
Start date July 26, 2017
Completion date September 12, 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04578249 - Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH N/A
Recruiting NCT06129942 - Light Therapy in Parkinson's Disease N/A
Recruiting NCT06083831 - The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients
Recruiting NCT05228444 - Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project N/A
Active, not recruiting NCT04953754 - Melatonin and Vaccine Response, Immunity, and Chronobiology Study N/A
Not yet recruiting NCT05452096 - SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health. N/A
Completed NCT01327040 - Light Sensitization Study N/A
Completed NCT03331822 - The Effects of Bright Light Exposure on ICU Nurses N/A
Completed NCT03646084 - Sleep and Circadian Intervention Program for Chronic Musculoskeletal Pain N/A
Recruiting NCT04690504 - Validation of Circadian Biomarkers in Patients With Sleep Disorders
Recruiting NCT06023654 - Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
Completed NCT03682185 - The Healthy Patterns Sleep Study Phase 3
Recruiting NCT06346613 - Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU
Recruiting NCT05309577 - Self-Care for Dementia Caregivers N/A
Completed NCT04157244 - The Music, Sleep and Dementia Study N/A
Completed NCT03468400 - Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire
Recruiting NCT04063332 - Functionality of Endogenous Biological Clock in Sepsis
Recruiting NCT06329479 - A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI) N/A
Recruiting NCT04401189 - The Role of Circadian Rhythms in Cancer-Related Symptoms
Completed NCT03684460 - Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients N/A