Chronic Fatigue SyndromePhase 4NCT01584934

Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

A Phase 4 study testing Sodium oxybate in people with Chronic Fatigue Syndrome, run by University Hospital, Ghent at 1 site in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Fatigue Syndrome
What is being tested?: Sodium oxybate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteBelgium
Study dates: Jun 2013to Dec 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients suffering from chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition;
Negatively screened for fibromyalgia syndrome(FMS) according to the American College of Rheumatology (ACR) classification criteria;
18 years or older;
65 years or less;
Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the trial and has to employ an acceptable method of birth control (double barrier method of contraception);
Written, signed and dated informed consent must be obtained from each patient;
Patient able to understand and follow the requirements of the study
Willing to abstain from taking any medication or treatment prohibited in the protocol

Who cannot join

FMS;
Presence of an inflammatory rheumatic disease or a painful disorder other than FMS;
Fatigue that is explained by medical or psychiatric causes;
Older than 65 or younger than 18 years of age;
Apnea/hypopnea index (AHI) > or equal to 15 on polysomnography (PSG) (exempted if receiving continuous positive airway pressure CPAP and shown good compliance)
Deficiency in succinic semialdehyde dehydrogenase;

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Porphyria;
Breathing or lung problems;
Unsufficiently controlled hypertension (high blood pressure: > 140/90 mmHg);
Heart failure;
Liver or kidney problems (serum creatinine level > 2,0 mg/dl);
Presence of a seizure disorder or epilepsy;
Sodium oxybate treatment in the past;
Primary history of substance abuse (including abuse of alcohol);
Inability to withdraw from psychoactive drugs;
Current use of sedative (benzodiazepine and non-benzodiazepine GABA-ergic agonists), opioids or antidepressant medication or a drug-free interval of less than 4 weeks;
Female patient who is pregnant, lactating or has a positive pregnancy test result.
Occupation that requires night-shift work;
Willing to abstain from using alcohol

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University Hospital
Ghent, 9000

Other trials in Belgium

About this study

Official title: The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS patients, however, the relationship between (disturbed) sleep quality and fatigue is still not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo controlled cross-over trial with sodium oxybate is carried out in CFS patients.

The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the effect of sodium oxybate on sleepiness and general health in the same target population.

Zero-hypothesis: there is no effect.

Conditions: Chronic Fatigue Syndrome
Being tested: Sodium oxybate, Placebo
Keywords: fatigue, sleep quality, Chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition
Medical subject headings: Fatigue Syndrome, Chronic, Fatigue, Sleep Initiation and Maintenance Disorders, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium oxybateDrug
Treatment is started and continued for 6 weeks at patient's home. Patients receive 3g/night during the first week, and 4,5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4,5 g/night for 1 week, followed by 3g/night for 1 week. The next 2 weeks, patients are not treated.
PlaceboDrug
Placebo treatment is started and continued for 6 weeks at patient's home. Patients receive 3 g/night during the first week and 4.5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4.5 g/night for 1 week, followed by 3 g/night for 1 week. The next 2 weeks, patients are not treated.

Study groups in NCT01584934
Study group	Role	What they receive
Sodium oxybate	Experimental	Patient group receives sodium oxybate as treatment. Receives: Drug: Sodium oxybate
Placebo	Placebo comparator	Patient group receives placebo as treatment. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measured: before treatment (baseline evaluation)
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measured: after 42 days of first treatment
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measured: after 42 days of second treatment (113 days after baseline)

Secondary outcomes (12)

Effect of sodium oxybate on sleepiness.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: before treatment (baseline evaluation)
Effect of sodium oxybate on sleepiness
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: after 42 days of first treatment
Effect of sodium oxybate on sleepiness.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: after 42 days of second treatment (113 days after baseline)
Effect of sodium oxybate on sleep quality.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: before treatment (baseline evaluation)
Effect of sodium oxybate on sleep quality.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: 42 days after first treatment
Effect of sodium oxybate on sleep quality.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: 42 days after second treatment (113 days after baseline)
Effect of sodium oxybate on general health.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: before treatment (baseline evaluation)
Effect of sodium oxybate on general health.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: 42 days after first treatment
Effect of sodium oxybate on general health.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: 42 days after second treatment (113 days after baseline)
Effect of sodium oxybate on pain.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: before treatment (baseline evaluation)
Effect of sodium oxybate on pain.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: 42 days after first treatment
Effect of sodium oxybate on pain.
Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.
Measured: 42 days after second treatment (113 days after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Dec 2015

First posted25 Apr 2012 (estimated)
Study startJun 2013
Primary completionJun 2015
Study completionDec 2015

Why it stopped: incompatibilities over intellectual property

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
More trials run by University Hospital, GhentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01584934
Sponsor's protocol ID: 2012/197
Other IDs: 2011-006336-23
Status last verified: Dec 2022
First submitted: 23 Apr 2012
Last updated: 15 Dec 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Fatigue Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
ClinicalTrials.gov ID: NCT01584934
Acronym / sponsor ID: 2012/197
Conditions: Chronic Fatigue Syndrome
Keywords: fatigue, sleep quality, Chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: incompatibilities over intellectual property
Enrolment: 0 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: UCB Pharma
Study start: Jun 2013 (actual)
Primary completion: Jun 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 25 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Zero-hypothesis: there is no effect.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Sodium oxybate	Experimental	Drug: Sodium oxybatePatient group receives sodium oxybate as treatment.
Placebo	Placebo comparator	Drug: PlaceboPatient group receives placebo as treatment.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients suffering from chronic, disabling, unexplained fatigue with at least 4 minor criteria for CFS, according to the 1994 Fukuda case definition;
Negatively screened for fibromyalgia syndrome(FMS) according to the American College of Rheumatology (ACR) classification criteria;
18 years or older;
65 years or less;
Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the trial and has to employ an acceptable method of birth control (double barrier method of contraception);

Key exclusion criteria (19 listed)

FMS;
Presence of an inflammatory rheumatic disease or a painful disorder other than FMS;
Fatigue that is explained by medical or psychiatric causes;
Older than 65 or younger than 18 years of age;
Apnea/hypopnea index (AHI) > or equal to 15 on polysomnography (PSG) (exempted if receiving continuous positive airway pressure CPAP and shown good compliance)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium oxybateTreatment is started and continued for 6 weeks at patient's home. Patients receive 3g/night during the first week, and 4,5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4,5 g/night for 1 week, followed by 3g/night for 1 week. The next 2 weeks, patients are not treated.	Drug	Sodium oxybate
PlaceboPlacebo treatment is started and continued for 6 weeks at patient's home. Patients receive 3 g/night during the first week and 4.5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4.5 g/night for 1 week, followed by 3 g/night for 1 week. The next 2 weeks, patients are not treated.	Drug	Placebo

Primary outcome

Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Time frame: before treatment (baseline evaluation)
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Time frame: after 42 days of first treatment
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).
Measurement of the effect of sodium oxybate on fatigue with questionnaires.
Time frame: after 42 days of second treatment (113 days after baseline)
Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).

12 secondary outcomes

Effect of sodium oxybate on sleepiness.
Time frame: before treatment (baseline evaluation)
Effect of sodium oxybate on sleepiness
Time frame: after 42 days of first treatment
Effect of sodium oxybate on sleepiness.
Time frame: after 42 days of second treatment (113 days after baseline)
Effect of sodium oxybate on sleep quality.
Time frame: before treatment (baseline evaluation)
Effect of sodium oxybate on sleep quality.
Time frame: 42 days after first treatment
Effect of sodium oxybate on sleep quality.
Time frame: 42 days after second treatment (113 days after baseline)
Effect of sodium oxybate on general health.
Time frame: before treatment (baseline evaluation)
Effect of sodium oxybate on general health.
Time frame: 42 days after first treatment
Effect of sodium oxybate on general health.
Time frame: 42 days after second treatment (113 days after baseline)
Effect of sodium oxybate on pain.
Time frame: before treatment (baseline evaluation)
Effect of sodium oxybate on pain.
Time frame: 42 days after first treatment
Effect of sodium oxybate on pain.
Time frame: 42 days after second treatment (113 days after baseline)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
Related InfoLink provided by the sponsor.

Related trials for Chronic Fatigue Syndrome

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

An Mariman, MD principal investigator

University Hospital, Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium oxybate in people with Chronic Fatigue Syndrome, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the effect of sodium oxybate on fatigue with questionnaires. (time frame: before treatment (baseline evaluation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01584934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.