SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)

NCT02055898 | Completed Phase 4 Results DMC

• 2 other identifiers: SAFFE20122012-002969-35
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Fatigue Syndrome

Keywords

Chronic fatigue syndrome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Drug: Sodium Oxybate; Other: placebo (fresh potable water)

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

Drug: Sodium Oxybate; Other: placebo (fresh potable water)

Interventions

Sodium Oxybate DRUG

Also known as: Xyrem

Placebo first, then sodium oxybate; Sodium oxybate first, then placebo

placebo (fresh potable water) OTHER

Placebo first, then sodium oxybate; Sodium oxybate first, then placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.
• Aged 25-65.
• Good grasp of the English language.

You may not qualify if:

• Taking any of the following medication: opioids, tramadol, phenytoin, valproate, ethosuximide, benzodiazepines, zolpidem, zopiclone, zaleplon, antidepressant except \<30mg amitriptyline, or any other medications likely to interact with sodium oxybate or with sleep in the opinion of the investigators.
• Current major psychiatric disorder.
• Unusual sleep schedule; (bedtime routines that fall outside 9 p.m. to 10 a.m.; usual time in bed \> 12 hours).
• Pregnancy, lactation or being female and not using reliable contraception.
• Relevant abnormal clinical findings at screening visit.
• Taken alcohol in the 24 hours before each study visit or drugs of abuse in the week before each study visit

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

Wellcome CRF, Imperial College, Hammersmith Campus

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Keith Boland
• Organization: Imperial College London

k.boland@imperial.ac.uk

Study Officials

• David Nutt, DM FRCPsych

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: February 5, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)