Clinical trial: A Study to Assess the Wakefulness Promoting Effect, Safety, Tolerability, and Pharmacokinetics (PK) of LML134 in Shift Work Disorder (NCT03141086)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female subjects 18 to 65 years of age included.

          -  Confirmed diagnosis of SWD according to ICSD-3 criteria at Screening.

          -  Subjects who are at least moderately ill with respect to sleepiness on work nights,
             including commute to and from work, as assessed by the Clinical Global
             Impression-Severity scale (CGI-S, score ≥4) at Screening.

          -  Subjects must work 5 or more night shifts per month, and 2 or more shifts must occur
             on consecutive nights, with 6 or more hours worked between 10 pm and 8 am, as
             confirmed by subject at Screening.

          -  Subjects must have mean sleep latency ≤8 minutes on nighttime MSLT at Screening.

          -  Subjects must weigh at least 50 kg at Screening to participate in the study, and must
             have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg)
             / [Height (m)]2

        Exclusion Criteria:

          -  Women of child-bearing potential (defined as all women physiologically capable of
             becoming pregnant) unless they are using highly effective methods of contraception
             from start of taking the study medication in the first period until stopping the
             medication in the second treatment period and for 3 additional days after AND an
             additional barrier method of contraception will be used while taking the study
             medication and for 3 additional days in both treatment periods.

          -  Sexually active males unwilling to use a condom during intercourse while taking
             investigational drug and for 3 days after stopping investigational drug. A condom is
             required for all sexually active male participants to prevent them from fathering a
             child AND to prevent delivery of the investigational drug via seminal fluid to their
             partner.

          -  Heavy smokers who smoke more than 10 cigarettes a day and occasional or light smokers
             (not more than 10 cigarettes per day) who are not willing to, or in their own or the
             investigators opinion are not able to refrain from tobacco/nicotine use for at least
             12 hours without nicotine craving or other withdrawal symptoms

          -  Subjects for whom it is not safe to discontinue or who are unwilling to discontinue
             use of modafinil, hypnotics, and antihistamines for the periods specified in the
             prohibited medication section.

          -  Heavy caffeine consumers, i.e. subjects who consume greater than 850 mg of caffeine
             per day (approximate equivalent of three tall cups of Starbucks coffee) in coffee,
             tea, or other caffeine-containing drinks.

          -  Subjects who have high risk of obstructive sleep apnea, indicated by score of 5 or
             more on the STOP-BANG questionnaire.

          -  Presence of any sleep disorder other than SWD, as confirmed by PSG at screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 25-year-old woman comes to the clinic with her roommate.  The roommate says that the patient has twice fallen asleep while they were talking.  The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap.  She also reveals that she sometimes hears a voice prior to falling asleep.  She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately.

Patient description (patient's own words): I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep.

Does the patient match the trial criteria? Contradiction