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Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients Clinical research trials and Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients. Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients clinical trial. Test subjects typically receive the most effective healthcare possible for their Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients  Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients
Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients
For Condition: Narcolepsy
Status: Recruiting
Sponsor(s): Orphan Medical ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
HarryCook, Study Director, Orphan Medical
Saint John Regional Hospital -- Somnology Program *Recruiting*
Saint John, New Brunswick, E2L4L2
Canada
Recruiting Brenda Lamb 506-648-7176
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Katherine Beck 919-668-2278
Peoria Pulmonary Associates, Ltd. *Recruiting*
Peoria, Illinois, 61603
United States
Recruiting Kimberly Hartwig 309-672-5682
Sleep Medicine Associates of Texas *Recruiting*
Plano, Texas, 75093
United States
Recruiting Jill Krows 972-312-0204
Palmetto Baptist Medical Center Sleep Disorders Center *Recruiting*
Columbia, South Carolina, 29201
United States
Recruiting Donna James 803-296-5847
VCU Health System MCV Hospitals - Sleep Disorders Center *Recruiting*
Richmond, Virginia, 23235
United States
Recruiting Heather Bonner 804-323-2255
Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting Christina Rossi 404-444-2302
Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Pashmina Rashad 757-668-1446
The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory *Recruiting*
Ottawa, Ontario, K1Y 4E9
Canada
Recruiting Mary Lewis 613-798-5555
Charleston Pulmonary Associates PA *Recruiting*
Charleston, South Carolina, 29403
United States
Recruiting Becky Hicks 843-572-3300
Washington University -- Sleep Medicine Center *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Pam Quertermus 314-747-0646
St. Petersburg Sleep Disorders Center *Recruiting*
St. Petersburg, Florida, 33707
United States
Recruiting Mary O'Brien 727-341-7676
Sleep Medicine Assoc PLLC -- Summit Medical Center *No longer recruiting*
Hermitage, Tennessee, 37076
United States
No longer recruiting
Raleigh Neurology Associates *Recruiting*
Raleigh, North Carolina, 27607
United States
Recruiting Tippi Garriss 919-420-1658
Stanford Sleep Disorders Clinic *Recruiting*
Stanford, California, 94305
United States
Recruiting Paul Stowers 650-498-6294
Fort Wayne Neurological Center *Recruiting*
Ft. Wayne, Indiana, 46804
United States
Recruiting Molly Miller 260-436-3991
Center for Sleep Diagnostics *Recruiting*
Newton, Massachusetts, 02459
United States
Recruiting Jennifer Mahoney 800-432-8808
Fort Wayne Neurological Center *Recruiting*
Ft. Wayne, Indiana, 46805
United States
Recruiting Molly Miller 260-436-3991
Chest Medicine Associates DBA/Sleep Medicine Specialists *Recruiting*
Louisville, Kentucky, 40217
United States
Recruiting Pam McCullough 502-479-1217
The Sleep Center - Community General Hospital *Recruiting*
Syracuse, New York, 13215
United States
Recruiting Antonio Culebras
Canadian Sleep Institute *Recruiting*
Calgary, Alberta, T2X2A8
Canada
Recruiting Ron Chisholm 403-254-3583
Sleep Disorder Centre -- Hopital du Sacre-Coeur *No longer recruiting*
Montreal, Quebec, H4J1C5
Canada
No longer recruiting
Low Country Lung and Critical Care PA *Recruiting*
Charleston, South Carolina, 29406-7108
United States
Recruiting Becky Hicks 843-572-3300
CSC Research -- Grove City Sleep Diagnostic Center *Recruiting*
Grove City, Ohio, 43123
United States
Recruiting Timothy Walter
Central Carolina Neurology & Sleep *Recruiting*
Salisbury, North Carolina, 28144
United States
Recruiting Sharon Leach 704-637-2261
Pacific Sleep Medicine Services *Recruiting*
La Jolla, California, 92037-1205
United States
Recruiting Nanette Mata 858-657-0550
Charleston Pulmonary Associates PA *Recruiting*
Mount Pleasant, South Carolina, 29464
United States
Recruiting Becky Hicks 843-572-3300
LSU Health Science Center *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Andrew Chesson
Southwest Cleveland Sleep Center *Recruiting*
Middleburg Heights, Ohio, 44130
United States
Recruiting Virginya Westover 440-239-7533
Sleep Disorders Center--Division of Neurology *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Cindy Nierodzik 847-570-2645
Sleep Disorders Center of Alabama, Inc. *Recruiting*
Birmingham, Alabama, 35213
United States
Recruiting Sheila Pegram 800-874-4948
The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology *Recruiting*
Toronto, Ontario, M5T 3A9
Canada
Recruiting Angela Cesta 416-323-2008
Center for Sleep and Wake Disorders *Recruiting*
Chevy Chase, Maryland, 20815
United States
Recruiting Jamie Stretz 301-654-0209
Department of Neurology *Recruiting*
Worcester, Massachusetts, 01608
United States
Recruiting Pam Sigel 508-363-7018
The Houston Sleep Center *Recruiting*
Houston, Texas, 77024
United States
Recruiting Sean O’Connor 713-465-9282
Sleep Disorders Center of Georgia *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Mike Bohannon 404-256-6545
Lynn Health Science Institute *Recruiting*
Oklahoma City, Oklahoma, 73112
United States
Recruiting Suzanne Goodrich 405-602-3956
Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Christina Rossi 404-444-2302
Swedish Sleep Medicine Institute *Recruiting*
Seattle, Washington, 98122
United States
Recruiting Dallas Parman 206-386-3714
Vancouver Hospital -- Sleep Disorders Clinic *Recruiting*
Vancouver, British Columbia, V6T2B5
Canada
Recruiting Sabina Hoffman 604-822-7857
Neurologische Poliklinik - Universitats Spital Zurich *Recruiting*
Zurich, , CH-8091
Switzerland
Recruiting Ramin Khatami 41-1-255-55-75
Sleep/Wake Center 7N2 -- Bellevue Hospital Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Bien Pagan 212-263-7130
The Center for Sleep and Wake Disorders/Midwest Neurology *Recruiting*
Danville, Indiana, 46122
United States
Recruiting Carrie Doub 317-718-1403
Brain & Sleep Diagnostic Center *No longer recruiting*
Toronto, Ontario, M8X2W2
Canada
No longer recruiting
Additional Information:
Study ID Numbers: OMC-SXB-15;
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049803
Other Narcolepsy Studies:
1. Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy
2. Trial Comparing Effects of Xyrem taken Orally and Modafinil with Placebo in Treating Daytime Sleepiness in Narcolepsy
3. Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients
4. CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
5. Sleep Disorders of Patients with Diseases of the Nervous System
Related Studies:
Other Narcolepsy Clinical Trials
Other Clinical Trials
Other Zurich Clinical Trials
Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients
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