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NarcolepsyPhase 3NCT00049803

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

A Phase 3 study testing sodium oxybate in people with Narcolepsy, run by Orphan Medical at 45 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Narcolepsy
What is being tested?
sodium oxybate
How many people
200 participants
Where
45 sitesin 3 countries
Study dates
Dec 2000to Apr 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

45 sites in 3 countries.

45 sites in 3 countries

United States37 sites

  • Sleep Disorders Center of Georgia

    Atlanta, Georgia, 30342

  • Sleep Disorders Center of Alabama, Inc.

    Birmingham, Alabama, 35213

  • Charleston Pulmonary Associates PA

    Charleston, South Carolina, 29403

  • Low Country Lung and Critical Care PA

    Charleston, South Carolina, 29406-7108

  • Center for Sleep and Wake Disorders

    Chevy Chase, Maryland, 20815

  • Palmetto Baptist Medical Center Sleep Disorders Center

    Columbia, South Carolina, 29201

  • The Center for Sleep and Wake Disorders/Midwest Neurology

    Danville, Indiana, 46122

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Sleep Disorders Center--Division of Neurology

    Evanston, Illinois, 60201

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • CSC Research -- Grove City Sleep Diagnostic Center

    Grove City, Ohio, 43123

  • Sleep Medicine Assoc PLLC -- Summit Medical Center

    Hermitage, Tennessee, 37076

  • The Houston Sleep Center

    Houston, Texas, 77024

  • Pacific Sleep Medicine Services

    La Jolla, California, 92037-1205

  • Chest Medicine Associates DBA/Sleep Medicine Specialists

    Louisville, Kentucky, 40217

  • Southwest Cleveland Sleep Center

    Middleburg Heights, Ohio, 44130

  • Charleston Pulmonary Associates PA

    Mt. Pleasant, South Carolina, 29464

  • Sleep/Wake Center 7N2 -- Bellevue Hospital Center

    New York, New York, 10016

  • Center for Sleep Diagnostics

    Newton, Massachusetts, 02459

  • Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital

    Norfolk, Virginia, 23507

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Peoria Pulmonary Associates, Ltd.

    Peoria, Illinois, 61603

  • Sleep Medicine Associates of Texas

    Plano, Texas, 75093

  • Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • VCU Health System MCV Hospitals - Sleep Disorders Center

    Richmond, Virginia, 23235

  • Central Carolina Neurology & Sleep

    Salisbury, North Carolina, 28144

  • Swedish Sleep Medicine Institute

    Seattle, Washington, 98122

  • LSU Health Science Center

    Shreveport, Louisiana, 71130

  • Washington University -- Sleep Medicine Center

    St Louis, Missouri, 63108

  • St. Petersburg Sleep Disorders Center

    St. Petersburg, Florida, 33707

  • Stanford Sleep Disorders Clinic

    Stanford, California, 94305

  • The Sleep Center - Community General Hospital

    Syracuse, New York, 13215

  • Clinical Pharmaceutical Trials, Inc.

    Tulsa, Oklahoma, 74104

  • Department of Neurology

    Worcester, Massachusetts, 01608

Other trials in United States

Canada7 sites

  • Canadian Sleep Institute

    Calgary, Alberta, T2X2A8

  • Sleep Disorder Centre -- Hopital du Sacre-Coeur

    Montreal, Quebec, H4J1C5

  • The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory

    Ottawa, Ontario, K1Y 4E9

  • Saint John Regional Hospital -- Somnology Program

    Saint John, New Brunswick, E2L4L2

  • The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology

    Toronto, Ontario, M5T 3A9

  • Brain & Sleep Diagnostic Center

    Toronto, Ontario, M8X2W2

  • Vancouver Hospital -- Sleep Disorders Clinic

    Vancouver, British Columbia, V6T2B5

Other trials in Canada

Switzerland1 site

  • Neurologische Poliklinik - Universitats Spital Zurich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official 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

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.

Conditions
Narcolepsy
Being tested
sodium oxybate
Keywords
Narcolepsy, Sodium Oxybate, Cataplexy, Excessive Daytime Sleepiness, GHB, Gamma Hydroxybutyric Acid, Orphan Medical, Orphan Drug
Medical subject headings
Narcolepsy, Cataplexy, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sodium oxybateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2002 (estimated)
  2. Study startDec 2000
  3. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049803
Sponsor's protocol ID
OMC-SXB-15
Status last verified
Jul 2004
First submitted
13 Nov 2002
Last updated
24 Jun 2005
Results posted
No

Publications

  • A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

    PubMed 11833860

  • Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90. doi: 10.1093/sleep/13.6.479.

    PubMed 2281247

  • Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20. doi: 10.1093/sleep/16.3.216.

    PubMed 8506453

  • A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.

    PubMed 12627729

  • Husain AM, Bujanover S, Ryan R, Scheckner B, Black J, Profant J. Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. J Clin Sleep Med. 2020 Sep 15;16(9):1469-1474. doi: 10.5664/jcsm.8530.

    PubMed 32356515

  • Roth T, Dauvilliers Y, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate on disrupted nighttime sleep in patients with narcolepsy. J Sleep Res. 2017 Aug;26(4):407-414. doi: 10.1111/jsr.12468. Epub 2016 Nov 3.

    PubMed 27807903

  • Bogan R, Swick T, Mamelak M, Kovacevic-Ristanovic R, Lai C, Black J, Villa KF, Montplaisir J. Evaluation of Quality of Life in Patients With Narcolepsy Treated With Sodium Oxybate: Use of the 36-Item Short-Form Health Survey in a Clinical Trial. Neurol Ther. 2016 Dec;5(2):203-213. doi: 10.1007/s40120-016-0053-5. Epub 2016 Oct 24.

    PubMed 27778193

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sodium oxybate in people with Narcolepsy, run by Orphan Medical at 45 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049803, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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