Clinical trial: Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients (NCT00049803)

Eligibility criteria:
INCLUSION CRITERIA

          -  Have signed & dated informed consent before beginning protocol procedures.

          -  Willing & able to complete entire trial as described in protocol.

          -  16 years of age or older.

          -  Have a history and presenting symptoms of excessive daytime sleepiness.

          -  Have a history of cataplexy localizable to a specific muscle group(s) or part(s) of
             body during which the patient is lucid (not experiencing an inadvertent nap or micro
             sleep).

          -  Have valid PSG & MSLT scores (collected during an overnight test) within last five
             years and a current diagnosis of narcolepsy according to the following criteria
             established by the American Sleep Disorders Association: (1) Recurrent daytime naps or
             lapses into sleep occur almost daily for at least 3 months; (2) Sudden bilateral loss
             of postural muscle tone occurs in association with intense emotion (cataplexy); (3)
             Polysomnography demonstrates one or more of the following: (a) Sleep latency less than
             10 minutes; (b) REM sleep latency less than 20 minutes; (c) An MSLT that demonstrates
             a mean sleep latency of less than 5 minutes; (d) Two or more sleep-onset REM periods

          -  Females who are surgically sterile, two years post-menopausal, or if of child-bearing
             potential, using a medically accepted method of birth control and agree to continue
             use of this method for the duration of the trial.

          -  In the opinion of the investigator, have adequate support for the duration of trial to
             include transportation to and from trial site. In addition, if in the investigator's
             assessment it is clinically indicated, the patient is willing to not operate a car or
             heavy machinery for the duration of the trial or for as long as the investigator deems
             clinically indicated.

        EXCLUSION CRITERIA

          -  Received gamma-hydroxybutyrate in the last 30 days.

          -  Have taken any investigational therapy within 30-day period prior to initial screening
             visit for this trial.

          -  Patients taking fluoxetine (Prozac).

          -  Have been diagnosed with sleep apnea syndrome, defined as an Apnea Index > 10 per hour
             or an Apnea Hypopnea Index greater than 15 per hour, or have any other cause of
             daytime sleepiness, and have any other disorder(s) that can be considered a primary
             cause of excessive daytime sleepiness.

          -  Taking hypnotics, tranquilizers, antihistamines (except for non-sedating
             antihistamines), benzodiazepines or clonidine at the start of the baseline period.
             Patients taking anticonvulsants are not eligible to participate even if willing to
             washout anticonvulsants for the trial.

          -  Experiencing unstable cardiovascular, endocrine, neoplastic (excluding localized basal
             cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic,
             neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which
             would place the patient at risk during the trial or compromise objectives outlined in
             the protocol.

          -  Have psychiatric disorders, major affective or psychotic disorders, or other problems
             that, in the investigator's opinion, would preclude the patient's participation and
             completion of this trial or compromise reliable representation of subjective symptoms.

          -  Have current or recent (within one year) history of a substance use disorder including
             alcohol abuse as defined by DSM-IV.

          -  Serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT [AST] or
             SGPT [ALT] more than twice the upper limit of normal), or elevated serum bilirubin
             (more than 1.5 times upper limit of normal), or pre-trial ECG results demonstrating
             clinically significant arrhythmias, greater than a first degree AV block or a history
             of myocardial infarction within last six months.

          -  Have an occupation that requires variable shift work or routine night shift.

          -  Have a clinically significant history of seizure disorder, a history of clinically
             significant head trauma (i.e., concussion resulting in clinically significant loss of
             consciousness) or past invasive intracranial surgery, and are taking anticonvulsant
             medications.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.


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