Clinical trial: A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 (NCT01463098)

Eligibility criteria:
Key Inclusion Criteria:

        Healthy Subjects:

          -  With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600
             to 0800

          -  Who report typical sleep latency of </= 30 minutes

          -  With typical total sleep time (TST) >/= 420 minutes

        Primary Insomnia Subjects:

          -  Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia
             (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text
             Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months

          -  With a score of > 15 on the Insomnia Severity Index (ISI) at Screening

          -  Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the
             past month

          -  Who report 6.5 hours sleep or less on at least 3 nights per week for the past month

          -  With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes
             with neither night < 15 minutes

          -  With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with
             neither night < 15 minutes or mean TST > 420 minutes

        Key Exclusion Criteria:

          -  With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg
             syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia
             (for Part B)

          -  Subjects with any clinically abnormal symptom or organ impairment found in medical
             history, symptoms/signs, vital signs, ECG finding, or laboratory test results which
             require medical treatment

          -  All females must be of non-childbearing potential

          -  With a known history of significant neurological or serious psychiatric illness
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 64 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