Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-30 @ 9:06 PM
Study NCT ID:
NCT00049803
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D002385', 'term': 'Cataplexy'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012978', 'term': 'Sodium Oxybate'}], 'ancestors': [{'id': 'D006885', 'term': 'Hydroxybutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'statusVerifiedDate': '2004-07', 'completionDateStruct': {'date': '2004-04'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2002-11-13', 'studyFirstSubmitQcDate': '2002-11-14', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-11-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Narcolepsy', 'Sodium Oxybate', 'Cataplexy', 'Excessive Daytime Sleepiness', 'GHB', 'Gamma Hydroxybutyric Acid', 'Orphan Medical', 'Orphan Drug'], 'conditions': ['Narcolepsy']}, 'referencesModule': {'references': [{'pmid': '11833860', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2281247', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8506453', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12627729', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32356515', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '27807903', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '27778193', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n* Have signed \\& dated informed consent before beginning protocol procedures.\n* Willing \\& able to complete entire trial as described in protocol.\n* 16 years of age or older.\n* Have a history and presenting symptoms of excessive daytime sleepiness.\n* 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).\n* 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\n* 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.\n* 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.\n\nEXCLUSION CRITERIA\n\n* Received gamma-hydroxybutyrate in the last 30 days.\n* Have taken any investigational therapy within 30-day period prior to initial screening visit for this trial.\n* Patients taking fluoxetine (Prozac).\n* 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.\n* 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.\n* 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.\n* 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.\n* Have current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by DSM-IV.\n* 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.\n* Have an occupation that requires variable shift work or routine night shift.\n* 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."}, 'identificationModule': {'nctId': 'NCT00049803', 'briefTitle': 'Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orphan Medical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OMC-SXB-15'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sodium oxybate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sleep Disorders Center of Alabama, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037-1205', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine Services', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Sleep Disorders Clinic', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Petersburg Sleep Disorders Center', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sleep Disorders Center of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sleep Disorders Center--Division of Neurology', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '61603', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Peoria Pulmonary Associates, Ltd.', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46122', 'city': 'Danville', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Center for Sleep and Wake Disorders/Midwest Neurology', 'geoPoint': {'lat': 39.7606, 'lon': -86.52639}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurological Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46805', 'city': 'Fort 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