Trial Outcomes & Findings for SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE) (NCT NCT02055898)
NCT ID: NCT02055898
Last Updated: 2020-11-18
Results Overview
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\^2/Hz)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
night 1
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Placebo Then Sodium Oxybate
7 patients with chronic fatigue syndrome
|
Sodium Oxybate Then Placebo
6 patients with chronic fatigue syndrome
|
|---|---|---|
|
First Intervention (5 Days)
STARTED
|
7
|
6
|
|
First Intervention (5 Days)
COMPLETED
|
5
|
5
|
|
First Intervention (5 Days)
NOT COMPLETED
|
2
|
1
|
|
Washout (at Least 14 Days)
STARTED
|
5
|
5
|
|
Washout (at Least 14 Days)
COMPLETED
|
5
|
5
|
|
Washout (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (5 Days)
STARTED
|
5
|
5
|
|
Second Intervention (5 Days)
COMPLETED
|
5
|
5
|
|
Second Intervention (5 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then Sodium Oxybate
7 patients with chronic fatigue syndrome
|
Sodium Oxybate Then Placebo
6 patients with chronic fatigue syndrome
|
|---|---|---|
|
First Intervention (5 Days)
Physician Decision
|
2
|
0
|
|
First Intervention (5 Days)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Baseline characteristics by cohort
| Measure |
Placebo First Then Sodium Oxybate
n=7 Participants
7 Patients who meet criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.
|
Sodium Oxybate First Then Placebo
n=6 Participants
6 Patients who meet criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: night 1Population: All participants who completed the study and whose recordings were adequate
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\^2/Hz)
Outcome measures
| Measure |
Sodium Oxybate
n=9 Participants
All participants who completed the study and whose recordings were adequate, during the sodium oxybate period
|
Placebo
n=9 Participants
All participants who completed the study, and whose recordings were adequate, during the placebo period
|
|---|---|---|
|
EEG Slow Wave Activity During Sleep
|
0.00002653 uV^2/Hz
Standard Error 0.00000406
|
0.00002257 uV^2/Hz
Standard Error 0.00000339
|
PRIMARY outcome
Timeframe: night 4Population: All participants who completed the study and whose recordings were adequate
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\^2/Hz)
Outcome measures
| Measure |
Sodium Oxybate
n=9 Participants
All participants who completed the study and whose recordings were adequate, during the sodium oxybate period
|
Placebo
n=9 Participants
All participants who completed the study, and whose recordings were adequate, during the placebo period
|
|---|---|---|
|
EEG Slow Wave Activity During Sleep
|
0.00003051 uV^2/Hz
Standard Error 0.00000492
|
0.00001759 uV^2/Hz
Standard Error 0.00000225
|
PRIMARY outcome
Timeframe: Day 2Population: All participants who completed the study and whose recordings were adequate
time to fall asleep in minutes
Outcome measures
| Measure |
Sodium Oxybate
n=10 Participants
All participants who completed the study and whose recordings were adequate, during the sodium oxybate period
|
Placebo
n=10 Participants
All participants who completed the study, and whose recordings were adequate, during the placebo period
|
|---|---|---|
|
Daytime Sleepiness
|
16.95 minutes
Standard Error 0.773
|
15.3 minutes
Standard Error 1.35
|
PRIMARY outcome
Timeframe: Day 5Population: All participants who completed the study
time to fall asleep in minutes
Outcome measures
| Measure |
Sodium Oxybate
n=10 Participants
All participants who completed the study and whose recordings were adequate, during the sodium oxybate period
|
Placebo
n=10 Participants
All participants who completed the study, and whose recordings were adequate, during the placebo period
|
|---|---|---|
|
Daytime Sleepiness
|
17.9 minutes
Standard Error 0.9
|
17.2 minutes
Standard Error 1.2
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sodium Oxybate
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
All participants who received at least one dose of placebo
|
Sodium Oxybate
n=11 participants at risk
All participants who received at least one dose of sodium oxybate
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea
|
16.7%
2/12 • Number of events 2 • 2 months
|
0.00%
0/11 • 2 months
|
|
Skin and subcutaneous tissue disorders
itchy skin
|
16.7%
2/12 • Number of events 2 • 2 months
|
9.1%
1/11 • Number of events 1 • 2 months
|
|
General disorders
painful legs at night
|
8.3%
1/12 • Number of events 1 • 2 months
|
0.00%
0/11 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
hay fever
|
8.3%
1/12 • Number of events 1 • 2 months
|
0.00%
0/11 • 2 months
|
|
Gastrointestinal disorders
Indigestion/upset stomach
|
0.00%
0/12 • 2 months
|
36.4%
4/11 • Number of events 4 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
central sleep apneas
|
0.00%
0/12 • 2 months
|
18.2%
2/11 • Number of events 2 • 2 months
|
|
General disorders
headache
|
0.00%
0/12 • 2 months
|
18.2%
2/11 • Number of events 2 • 2 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/12 • 2 months
|
9.1%
1/11 • Number of events 1 • 2 months
|
|
General disorders
unsteadiness
|
0.00%
0/12 • 2 months
|
9.1%
1/11 • Number of events 1 • 2 months
|
|
General disorders
feels confused on waking
|
0.00%
0/12 • 2 months
|
18.2%
2/11 • Number of events 2 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place