Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

December 21, 2011 updated by: Jazz Pharmaceuticals

Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy

This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Cedex 13
      • Paris, Cedex 13, France, 75651
        • Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil
    • Cedex 5
      • Montpellier, Cedex 5, France, 34295
        • Centre du sommeil -- Hopital Gui de Chauliac
  • Germany
      • Regensburg, Germany, 93042
        • Psychiatrische Universitätsklinik
  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Neurologische Poliklinik -- Universitats Spital Zurich
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates, PA
    • California
      • Fullerton, California, United States, 92835
        • St. Jude Medical Center -- Sleep Disorders Institute
      • Los Angeles, California, United States, 90048
        • Pacific Sleep Medicine Services, Inc.
      • Pasadena, California, United States, 91105
        • Neuro-Therapeutics, Inc.
      • San Diego, California, United States, 92121
        • Pacific Sleep Medicine Services, Inc.
      • Stanford, California, United States, 94305
        • Stanford Sleep Disorders Clinic
    • Florida
      • St. Petersburg, Florida, United States, 33707
        • Clinical Research Group of St. Petersburg, Inc.
    • Illinois
      • Peoria, Illinois, United States, 61603
        • Peoria Pulmonary Associates, LTD
    • Indiana
      • Danville, Indiana, United States, 46122
        • The Center for Sleep and Wake Disorders/Midwest Neurology
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic
      • Crestview Hills, Kentucky, United States, 41017
        • Community Research & Sleep Management Institute
      • Louisville, Kentucky, United States, 40217
        • Chest Medicine Associates DBA -- Sleep Medicine Specialists
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Center for Sleep & Wake Disorders
      • Elkton, Maryland, United States, 21921
        • Sleep Disorders Center -- Union Hospital of Cecil County
      • Towson, Maryland, United States, 21204
        • Sleep Medicine Associates of Maryland
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington University Sleep Center
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • New Jersey Neuroscience Institute at JFK Medical Center
    • New York
      • Rochester, New York, United States, 14618
        • Sleep Disorders Center of Rochester
      • Rochester, New York, United States, 14618
        • Strong Sleep Disorders Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Winston-Salem, North Carolina, United States, 27103
        • ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati Clinic & Sleep Management Institute
      • Cincinnati, Ohio, United States, 45219
        • Community Research Management Associates,Inc.
      • Grove City, Ohio, United States, 43123
        • CSC Research -- Grove City Sleep Diagnostic Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Hospital Sleep Disorders Center
      • Carlisle, Pennsylvania, United States, 17013
        • Capital Region Sleep Disorder Center
      • Lafayette Hill, Pennsylvania, United States, 19444
        • Center for Sleep Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29406-7108
        • Lowcountry Lung and Critical Care, PA
      • Columbia, South Carolina, United States, 29220
        • Sleepmed of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • SDHRF Clinical Research Center
      • Sioux Falls, South Dakota, United States, 57105
        • Sioux Valley Clinic -- Pulmonary
      • Sioux Falls, South Dakota, United States, 57105
        • Sleep Disorders Center
    • Texas
      • Lubbock, Texas, United States, 79410
        • Bhupesh Dihenia, MD
      • San Antonio, Texas, United States, 78229
        • SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd.
    • Vermont
      • Essex Junction, Vermont, United States, 05452
        • Vermont Medical Sleep Disorders Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

Patients will be included in the trial if they:

  • Have signed and dated an informed consent prior to beginning protocol required procedures.
  • Are willing and able to complete the entire trial as described in the protocol.
  • Are 18 years of age or older.
  • Fulfill the International Classification of Sleep Disorders criteria for the diagnosis of narcolepsy.
  • Are taking stable doses of modafinil (200 to 600 mg/day) for the treatment of daytime sleepiness for a period of three months or greater and the modafinil dose has been stable for at least 1 month prior to entering this trial
  • Females may be included who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) 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 the trial to include transportation to and from the 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

Patients will be excluded from the trial if they:

  • Have received gamma-hydroxybutyrate in the last 30 days.
  • Have taken any investigational therapy within the 30-day period prior to the initial screening visit (Visit 1) for this trial.
  • Have sleep apnea syndrome, defined as an Apnea Index > 10 per hour or an AHI (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 (e.g., severe periodic leg movement syndrome as determined by the investigator, sleep apnea, sleep deprivation).
  • Are 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 event if they are willing to washout anticonvulsants for the trial.
  • Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, 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 the 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 a current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by the DSM-IV.
  • Have a 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 the 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 the last six months.
  • Have an occupation that requires variable shift work or routine night shift.
  • Have a clinically significant history of seizure disorder either past or present, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1.
Xyrem + Modafinil Placebo
Drug: Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Other Names:
  • Sodium Oxybate
Drug: Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Other Names:
  • Provigil Placebo
Placebo Comparator: Group 2:
Xyrem Placebo + Modafinil Placebo
Drug: Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Other Names:
  • Provigil Placebo
Drug: Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Other Names:
  • Sodium Oxybate Placebo
Active Comparator: Group 3
Xyrem Placebo + Modafinil at established dose
Drug: Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Other Names:
  • Sodium Oxybate Placebo
Drug: Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Other Names:
  • Provigil
Experimental: Group 4:
Xyrem + Modafinil at established dose
Drug: Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Other Names:
  • Sodium Oxybate
Drug: Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Other Names:
  • Provigil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
Time Frame: Baseline to Week 8
The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yanping Zheng, MD, Jazz Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OMC-SXB-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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