Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002969-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
The investigators wish to investigate whether enhancement of SWS, which is seen after a drug called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function, specifically sleepiness and mental performance. This is a safe and well-tolerated drug that is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.
The investigators will study 12 patients diagnosed with CFS using international diagnostic guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be taken nightly, and the investigators will measure next-day sleepiness, mental performance and fatigue, and compare drug and placebo nights.
Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment and other symptoms, is associated with neither a currently identifiable disease process nor major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep impairment is common in nearly everyone with CFS, with both daytime sleepiness and unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be that fundamental regulatory processes that control sleep are disturbed in CFS, leading to different effects on sleep and daytime symptoms depending on the subject's prior sleep, daytime routine, medication and other factors. The investigators contacts with patient groups have indicated that patients are generally confident that on days when their sleep is better they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo first, then sodium oxybate | Experimental | Subjects received a single dose of placebo comparator (fresh potable water) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of sodium oxybate (3.0g as liquid) at bedtime for 4 nights |
|
| Sodium oxybate first, then placebo | Experimental | Subjects received a single dose of sodium oxybate (3.0g as liquid) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of placebo comparator (fresh potable water) at bedtime for 4 nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Oxybate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Slow Wave Activity During Sleep | Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz) | night 1 |
| EEG Slow Wave Activity During Sleep | Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz) | night 4 |
| Daytime Sleepiness | time to fall asleep in minutes | Day 2 |
| Daytime Sleepiness | time to fall asleep in minutes | Day 5 |
Not provided
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Nutt, DM FRCPsych | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome CRF, Imperial College, Hammersmith Campus | London | W12 0NN | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Sodium Oxybate | 7 patients with chronic fatigue syndrome |
| FG001 | Sodium Oxybate Then Placebo | 6 patients with chronic fatigue syndrome |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (5 Days) |
|
| |||||||||||||||||||||
| Washout (at Least 14 Days) |
| ||||||||||||||||||||||
| Second Intervention (5 Days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo First Then Sodium Oxybate | 7 Patients who meet criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems. |
| BG001 | Sodium Oxybate First Then Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | EEG Slow Wave Activity During Sleep | Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz) | All participants who completed the study and whose recordings were adequate | Posted | Mean | Standard Error | uV^2/Hz | night 1 |
|
2 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | All participants who received at least one dose of placebo | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstructive sleep apnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Boland | Imperial College London | k.boland@imperial.ac.uk |
Not provided
| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo (fresh potable water) |
| Other |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
6 Patients who meet criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | EEG Slow Wave Activity During Sleep | Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz) | All participants who completed the study and whose recordings were adequate | Posted | Mean | Standard Error | uV^2/Hz | night 4 |
|
|
|
| Primary | Daytime Sleepiness | time to fall asleep in minutes | All participants who completed the study and whose recordings were adequate | Posted | Mean | Standard Error | minutes | Day 2 |
|
|
|
| Primary | Daytime Sleepiness | time to fall asleep in minutes | All participants who completed the study | Posted | Mean | Standard Error | minutes | Day 5 |
|
|
|
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Sodium Oxybate | All participants who received at least one dose of sodium oxybate | 0 | 11 | 0 | 11 | 5 | 11 |
| itchy skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | mild itchiness |
|
| painful legs at night | General disorders | Non-systematic Assessment |
|
| hay fever | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Indigestion/upset stomach | Gastrointestinal disorders | Non-systematic Assessment | including mild nausea |
|
| central sleep apneas | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | as recorded with overnight polysomnography |
|
| headache | General disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| unsteadiness | General disorders | Non-systematic Assessment |
|
| feels confused on waking | General disorders | Non-systematic Assessment | Brief period of disorientation on waking |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |