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Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

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ClinicalTrials.gov Identifier: NCT00498485
Recruitment Status : Terminated (Withdrawal of support.)
First Posted : July 10, 2007
Results First Posted : April 21, 2016
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Fatigue Syndrome
Interventions Drug: Placebo
Drug: Sodium Oxybate
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Xyrem
Hide Arm/Group Description 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: Same as for Placebo
Period Title: Overall Study
Started 7 10
Completed 6 5
Not Completed 1 5
Reason Not Completed
Adverse Event             1             5
Arm/Group Title Placebo Xyrem Total
Hide Arm/Group Description 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: Same as for Placebo Total of all reporting groups
Overall Number of Baseline Participants 7 10 17
Hide Baseline Analysis Population Description
No info available
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
10
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Female
7
 100.0%
10
 100.0%
17
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 10 participants 17 participants
7 10 17
Initial illness severity rating  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
7 10 17
1.Primary Outcome
Title Global Assessment of Change
Hide Description A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 [much better] thru 0 [no change] to -2 [much worse]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Had we completed the study, the analysis would have been a comparison of counts of those reporting being very much improved across the two treatment conditions
Arm/Group Title Placebo Drug Treated
Hide Arm/Group Description:
Xyrem: Volunteers will complete questionnaires. 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.
Xyrem: Volunteers will complete questionnaires. 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.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
6 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Drug Treated
Comments Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Self Reported Assessment of Sleep
Hide Description Subjects were asked to provide their input as to the quality of their sleep over the past week
Time Frame Assessed at week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
While data were collected, these data were never analyzed because the study was terminated prematurely by the sponsor and were lost when PI moved from UMDNJ to Beth Israel in NYC in 2008.
Arm/Group Title Placebo Xyrem
Hide Arm/Group Description:
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: Same as for Placebo
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Xyrem
Hide Arm/Group Description 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: Same as for Placebo
All-Cause Mortality
Placebo Xyrem
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Xyrem
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Xyrem
Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   5/10 (50.00%) 
Gastrointestinal disorders     
Gastric upset *  1/7 (14.29%)  5/10 (50.00%) 
*
Indicates events were collected by non-systematic assessment
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.
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
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
First Submitted: July 2, 2007
First Posted: July 10, 2007
Results First Submitted: May 15, 2015
Results First Posted: April 21, 2016
Last Update Posted: May 19, 2016