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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00049803
Date of registration: 13/11/2002
Prospective Registration: No
Primary sponsor: Orphan Medical
Public title: Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
Scientific title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) With Placebo for the Treatment of Narcolepsy
Date of first enrolment: December 2000
Target sample size: 200
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00049803
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Canada Switzerland United States
Contacts
Name:     Harry N Cook, MBA, RPh
Address: 
Telephone:
Email:
Affiliation:  Orphan Medical
Name:     William Houghton, MD
Address: 
Telephone:
Email:
Affiliation:  Orphan Medical
Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Narcolepsy
Intervention(s)
Drug: sodium oxybate
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
OMC-SXB-15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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