Chronic fatigue syndrome MedDRA version: 16.0 Level: PT Classification code 10008874 Term: Chronic fatigue syndrome System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Xyrem
Product Name: Xyrem
Product Code: EMEA/H/C/000593
Pharmaceutical Form: Oral solution
INN or Proposed INN: sodium oxybate
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Meeting criteria for CFS according to both the revised CDC and Canadian diagnostic systems Aged 25-65 Good grasp of the English language Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Taking medication which interferes with sodium oxybate metabolism including tramadol, phenytoin, valproate, or medication that would interfere with sleep including benzodiazepines, Z hypnotics, antidepressant except 12 hours) Pregnancy, lactation or being female and not using reliable contraception Relevant abnormal clinical findings at screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question is to determine whether pharmacological enhancement of slow-wave sleep with sodium oxybate improves sleep maintenance and reduces the impact of sleep disruption in chronic fatigue syndrome on daytime function, specifically sleepiness and cognitive function. ;Secondary Objective: The secondary objectives are to determine whether pharmacological enhancement of slow-wave sleep with sodium oxybate in chronic fatigue syndrome is associated with changes in: subjectively rated sleep, sleepiness and mood; neuropsychological functioning; and muscle fatigue. ;Primary end point(s): Difference in slow-wave activity between sodium oxybate and placebo on night 4 Difference between sodium oxybate and placebo on MSLT on day 5 ;Timepoint(s) of evaluation of this end point: Night 4 and day 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Differences between placebo and active drug on • Slow-wave sleep and slow wave activity on night 1 • All other stages of sleep on all nights • Subjectively rated sleep, sleepiness and mood • Neuropsychological tests (CANTAB) • Dynamometer measures of muscle fatigue ;Timepoint(s) of evaluation of this end point: All nights and day 5. | — |
Countries
United Kingdom
Outcome results
None listed