Overview

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

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
0
Participant gender:
All
Summary
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be evaluated. Participants are allowed to continue using stimulant medications at constant doses during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the sleep center will be required to complete the study.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Orphan Medical
Treatments:
Sodium Oxybate
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.