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Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Sodium Oxybate
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring chronic, fatigue, pain, sleep, xyrem, must have chronic fatigue syndrome, no hypertension, no sleep apnea

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• I have CFS

Exclusion Criteria:

  • I do not meet the above criteria
  • I have a lifelong history of fatigue
  • I have Fibromyalgia
  • I have hypertension
  • I am pregnant or breastfeeding

Sites / Locations

  • UMDNJ - Pain & Fatigue Study Center, ADMC 1618

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Sodium Oxybate

Arm Description

Patients were randomized and these received placebo

Patients were randomized and these received the active drug

Outcomes

Primary Outcome Measures

Global Assessment of Change
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]
Self Reported Assessment of Sleep
Subjects were asked to provide their input as to the quality of their sleep over the past week

Secondary Outcome Measures

Full Information

First Posted
July 2, 2007
Last Updated
May 18, 2016
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00498485
Brief Title
Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome
Official Title
Phase IV - A Trial of Xyrem in the Treatment of Chronic Fatigue Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Withdrawal of support.
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to produce the rapid onset of deep sleep is a reason it became a street drug, but its availability is currently limited via distribution through a single centralized pharmacy. Xyrem has been successfully used based on results from a study on patients with fibromyalgia (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from this study just which patient may be helped. I have prescribed Xyrem for patients who have both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I propose testing the drug's efficacy on patients with CFS alone - that is, they do not have fibromyalgia. Volunteers for this study will complete paper and pencil questionnaires about their symptoms as well as a computerized test to assess their degree of brain fog. They will then be randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group they are in until the end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks identical to 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 be told to skip taking the second dose. We will call patients weekly to see how they are doing on the "drug." If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect of treatment, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
Detailed Description
Medically unexplained fatigue occurs in about 5% of the population with 10% of that number fulfilling formal case definitions for chronic fatigue syndrome1. Medically unexplained fatigue is a major problem for both patient and practitioner - for both because there is no effective FDA-approved treatment for the symptom. One major problem for these patients is unrefreshing sleep. Formal sleep studies show reduced total sleep time and reduced sleep efficiency compared to controls.2;3 We are currently in the early stages of an NIH-funded grant designed to study cytokines during sleep. Preliminary results support awake time for patients relative to controls, producing a decreased sleep efficiency. These data lead to our working hypothesis that the problem of severe daytime fatigue is due to a previously unappreciated form of sleep pathology related to sleep fragmentation. Patients with medically unexplained pain also complain of disturbed sleep. Sodium oxybate has been tested on patients with this complaint who fulfill a formal case definition for fibromyalgia and has found to reduce symptoms and improve sleep quality.4 Specifically, six of 7 pain/fatigue scores (overall pain, pain at rest, pain during movement, end of day fatigue, overall fatigue, and morning fatigue) were relieved by 29% to 33% with sodium oxybate, compared with 6% to 10% relief with placebo (p < 0.005). Alpha intrusion indicative of disturbed sleep, sleep latency, and rapid-eye-movement sleep were significantly decreased, while slow-wave (stage 3/4) sleep was significantly increased, compared with placebo (p < 0.005). Two of the 5 subjective sleep related variables were significantly different from placebo: morning alertness (improved by 18% with sodium oxybate, compared with 2% for placebo; p = 0.0033) and quality of sleep (improved by 33% and 10%, respectively; p = 0.0003). Importantly, approximately 40% of patients in my study group fulfill case definitions simultaneously for CFS and FM. Since we do not know if patients in either sodium oxybate treatment trial had CFS, we cannot be sure whether efficacy was specific for FM or instead may have occurred due to the fact that a large representation of CFS had occurred. An unpublished Phase II randomized double-blind placebo controlled trial in FM, done by Jon Russell and colleagues in Dallas and presented at the 2005 meeting of the American College of Rheumatology, reported substantial symptom improvement with statistically significant benefits in self reported pain scales and patient global impression of improvement at both doses of sodium oxybate tested compared with placebo [4.5g [9ml] total dose per night; p=0.005 and 6g [12 ml], p=0.048]. Improvement in outcome variables was 34.5% at the 4.5g and 27.3% at the 6g compared to 12.5% in the placebo group. I have prescribed sodium oxybate in my own practice for patients who have both CFS and FM with good results. Anecdotally, patients reporting less pain also reported better quality sleep and less fatigue upon awakening. This has led me to hypothesize that sodium oxybate will reduce fatigue in patients with CFS alone (i.e., without also having FM). To test this hypothesis, I propose doing a double blind, placebo controlled trial of sodium oxybate in 30 patients who fulfill a formal case definition for chronic fatigue syndrome and who do not also have FM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
chronic, fatigue, pain, sleep, xyrem, must have chronic fatigue syndrome, no hypertension, no sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients were randomized and these received placebo
Arm Title
Sodium Oxybate
Arm Type
Active Comparator
Arm Description
Patients were randomized and these received the active drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come 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 predetermined maximum is reached.
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate
Other Intervention Name(s)
Xyrem
Intervention Description
Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come 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 predetermined maximum is reached.
Primary Outcome Measure Information:
Title
Global Assessment of Change
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
Title
Self Reported Assessment of Sleep
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • I have CFS Exclusion Criteria: I do not meet the above criteria I have a lifelong history of fatigue I have Fibromyalgia I have hypertension I am pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Natelson, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ - Pain & Fatigue Study Center, ADMC 1618
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

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