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

This study has been completed.
Sponsor:
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00066170
First received: August 4, 2003
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
Results First Received: October 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Narcolepsy
Interventions: Drug: Xyrem
Drug: Xyrem Placebo
Drug: Modafinil at established dose
Drug: Modafinil (Placebo)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Xyrem Placebo + Modafinil Placebo Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem + Modafinil Placebo Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem Placebo + Modafinil at Established Dose Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
Xyrem + Modafinil at Established Dose Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.

Participant Flow:   Overall Study
    Xyrem Placebo + Modafinil Placebo     Xyrem + Modafinil Placebo     Xyrem Placebo + Modafinil at Established Dose     Xyrem + Modafinil at Established Dose  
STARTED     56     55     63     57  
Intent to Treat     55     50     63     54  
COMPLETED     49     45     59     48  
NOT COMPLETED     7     10     4     9  
Adverse Event                 2                 4                 1                 7  
Serious Adverse Event                 0                 0                 1                 1  
Lost to Follow-up                 0                 1                 0                 0  
Non-Compliance with Trial Medicine                 1                 0                 0                 1  
Protocol Violation                 3                 0                 0                 0  
Other                 1                 5                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Xyrem Placebo + Modafinil Placebo Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem + Modafinil Placebo Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
Xyrem Placebo + Modafinil at Established Dose Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
Xyrem + Modafinil at Established Dose Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
Total Total of all reporting groups

Baseline Measures
    Xyrem Placebo + Modafinil Placebo     Xyrem + Modafinil Placebo     Xyrem Placebo + Modafinil at Established Dose     Xyrem + Modafinil at Established Dose     Total  
Number of Participants  
[units: participants]
 		  55     50     63     54     222  
Age  
[units: years]
Mean ± Standard Deviation 		  41.0  ± 13.35     35.1  ± 12.86     38.9  ± 15.62     38.9  ± 15.87     38.6  ± 14.60  
Gender  
[units: participants]
 		         
Female     31     24     31     29     115  
Male     24     26     32     25     107  
Race/Ethnicity, Customized  
[units: Participants]
 		         
Caucasian     43     47     57     48     195  
Black     11     2     5     3     21  
Asian     0     1     0     0     1  
Hispanic     1     0     0     1     2  
Other     0     0     1     2     3  



  Outcome Measures

1.  Primary:   Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)   [ Time Frame: Baseline to Week 8 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Grace Wang, MD Director of Clinical Development & Medical Monitor
Organization: Jazz Pharmaceuticals, Inc
phone: 650-496-3777


Publications of Results:

Other Publications:


Responsible Party: Senior Director Clinical Development, Jazz Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00066170     History of Changes
Other Study ID Numbers: OMC-SXB-22
Study First Received: August 4, 2003
Results First Received: October 21, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration