Clinical trial: A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without Cataplexy (NCT04072380)

Eligibility criteria:
Inclusion Criteria:

          -  Ages of 18 to 50 years (adult), inclusive.

          -  Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International
             Classification of Sleep Disorders (3rd edition) criteria (new or previously
             diagnosed).

          -  Have undergone an multiple sleep latency test (MSLT) within the previous 15 years
             showing an MSLT of ≤ 8 minutes.

          -  An ESS score of ≥ 12; and mean MWT time of < 12 min.

          -  Body mass index ranging from 18 to < 45 kg/m2

          -  Negative urine drug screen.

          -  A woman must be either not of childbearing potential or of childbearing potential
             practicing highly effective methods of birth control.

          -  Willingness to complete the study protocol with full compliance with procedures and
             sign an informed consent form (ICF).

        Exclusion Criteria:

          -  Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of <
             6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.

          -  Use of any investigational therapy (including pitolisant) within the 30-day period
             prior to enrollment.

          -  Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline
             assessments and during the course of the trial.

          -  Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens
             at night to smoke).

          -  Use of concurrent medications prescribed to treat narcolepsy as specified including
             stimulants, antidepressants and sodium oxybate.

          -  Current diagnosis of or past treatment for syndromes known to cause sleep disruption
             or any other cause of daytime sleepiness.

          -  Clinically significant ECG abnormalities.

          -  An occupation requiring variable shift work, night shifts, or frequent overnight
             travel which disrupts sleep patterns.
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 50 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? Entailment