Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

NCT00498485 | Terminated Phase 4 Results

• 1 other identifier: 0120060315
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

chronic; fatigue; pain; sleep; xyrem; must have chronic fatigue syndrome; no hypertension; no sleep apnea

Outcome Measures

Primary Outcomes (2)

• 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 \[much worse\]

  6 weeks

• Self Reported Assessment of Sleep

  Subjects were asked to provide their input as to the quality of their sleep over the past week

  Assessed at week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients were randomized and these received placebo

Drug: Placebo

Sodium Oxybate

ACTIVE COMPARATOR

Patients were randomized and these received the active drug

Drug: Sodium Oxybate

Interventions

Placebo DRUG

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.

Placebo

Sodium Oxybate DRUG

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.

Also known as: Xyrem

Sodium Oxybate

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I have CFS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

UMDNJ - Pain & Fatigue Study Center, ADMC 1618

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Bronchiolitis Obliterans Syndrome; Fatigue; Pain

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Benjamin Natelson
• Organization: Rutgers

bnatelson@chpnet.org

973-2236370

Study Officials

• Benjamin Natelson, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 10, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 19, 2016
• Results First Posted: April 21, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)