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Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

This study has been terminated.
(Withdrawal of support.)
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00498485
First received: July 2, 2007
Last updated: May 18, 2016
Last verified: February 2016
Results First Received: May 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Fatigue Syndrome
Interventions: Drug: Placebo
Drug: Sodium Oxybate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
Xyrem Xyrem: Same as for Placebo

Participant Flow:   Overall Study
    Placebo     Xyrem  
STARTED     7     10  
COMPLETED     6     5  
NOT COMPLETED     1     5  
Adverse Event                 1                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No info available

Reporting Groups
  Description
Placebo Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
Xyrem Xyrem: Same as for Placebo
Total Total of all reporting groups

Baseline Measures
    Placebo     Xyrem     Total  
Number of Participants  
[units: participants]
  7     10     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     10     17  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     7     10     17  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     7     10     17  
Initial illness severity rating  
[units: participants]
  7     10     17  



  Outcome Measures
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1.  Primary:   Global Assessment of Change   [ Time Frame: 6 weeks ]

2.  Primary:   Self Reported Assessment of Sleep   [ Time Frame: Assessed at week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Too few subjects to get any definitive data. Based on the preliminary data analysis done with available subjects, we infer that had we completed the study, we might have found a significant effect for drug treated over placebo treated subjects.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr Benjamin Natelson
Organization: Rutgers
phone: 973-2236370
e-mail: bnatelson@chpnet.org



Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00498485     History of Changes
Other Study ID Numbers: 0120060315
Study First Received: July 2, 2007
Results First Received: May 15, 2015
Last Updated: May 18, 2016
Health Authority: United States: Institutional Review Board