In short
There are currently 2 ongoing clinical trials exploring new treatment options for Chronic Fatigue Syndrome. Both studies are investigating the medication daratumumab in patients with moderate to severe forms of the condition. (Also known as: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, ME/CFS)
Clinical trial locations
- Norway
Study on Daratumumab for Reducing Symptoms in Patients with Moderate to Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
This study is taking place in Norway and aims to evaluate whether daratumumab can help reduce symptoms in people living with moderate to severe forms of the condition. The trial will last for 26 weeks, with participants receiving the medication through subcutaneous injections (injections under the skin).
Who can participate:
This trial is looking for participants who meet the following criteria:
- Have a diagnosis according to Canadian guidelines, with symptoms severe enough that you are mostly staying at home or partly bedridden
- Are between 18 and 64 years old
- Have had the condition for at least two years
- Can identify a clear starting point to your symptoms, such as after an infection or another immune system trigger
- Have a specific level of NK-cells (immune cells) in your blood of at least 125 x109/L
- Women of childbearing potential must have a negative pregnancy test and use effective birth control for at least four weeks before treatment and continue for 24 weeks after the last injection
Who cannot participate:
You will not be able to join this study if you:
- Have any other serious medical condition that might interfere with the study
- Are currently in another clinical trial
- Have had a recent infection or illness that could affect results
- Are pregnant or breastfeeding
- Have a history of allergic reactions to the study medication or similar drugs
- Have a history of substance abuse or dependency
- Have been diagnosed with a psychiatric disorder that could interfere with the study
- Have a history of cancer (except for certain types of skin cancer)
- Are unable to attend follow-up visits or comply with study procedures
What the study involves:
The trial is testing daratumumab, a medication that is an antibody targeting a specific protein called CD38 found on certain cells in the body. Participants will receive either daratumumab or a placebo to compare the effects. Throughout the 26-week study period, researchers will closely monitor participants' symptoms, physical function, and daily activity levels to see if the medication helps alleviate symptoms and improve quality of life. Follow-up assessments will continue until week 60.
Investigational drug: Daratumumab is a monoclonal antibody that targets the CD38 protein. It is being tested to see if it can help reduce symptoms by targeting specific cells in the immune system.
Study of Daratumumab Injections for Patients with Moderate to Severe Chronic Fatigue Syndrome
This study, also conducted in Norway, is focused on evaluating the feasibility and safety of daratumumab in patients with moderate to severe symptoms. The trial will involve ten patients who will receive the medication over a set period of time.
Who can participate:
The study is seeking participants who:
- Have moderate to severe symptoms that significantly affect daily life
- Meet the Canadian consensus criteria for diagnosis
- Are between 18 and 65 years old
- Have had the condition for at least two years
- Have a clear start to the illness, such as beginning after an infection
- Can provide signed informed consent
Who cannot participate:
You cannot join this study if you:
- Have a known allergy or severe reaction to the study medication or its ingredients
- Are currently in another clinical trial or participated in one within the last 30 days
- Have a history of certain types of cancer, unless you have been in complete remission for at least 5 years
- Have uncontrolled or severe heart problems, such as heart failure or a recent heart attack
- Have severe liver or kidney disease that is not well managed
- Are pregnant or breastfeeding
- Have any other medical condition that study doctors believe would make it unsafe to participate
- Are unable to comply with study procedures or follow-up visits
What the study involves:
This trial focuses on safety and feasibility, examining how well patients tolerate the treatment and any potential benefits it may provide. Participants will receive daratumumab through subcutaneous injections according to a schedule determined by the study. Researchers will track various aspects of participants' health, including physical function, bodily pain, and overall activity levels using questionnaires and assessments. The monitoring period extends to 40 weeks from the start of treatment, allowing researchers to collect comprehensive data on the medication's impact.
Investigational drug: Daratumumab (DARZALEX 1800 mg solution for injection) is an anti-CD38 antibody that targets specific cells in the immune system. It is being tested to see if it can help manage symptoms by modulating immune responses.
Summary
Both ongoing clinical trials for Chronic Fatigue Syndrome are concentrated in Norway and are investigating the same medication, daratumumab. This focus reflects an emerging research interest in understanding whether targeting the immune system through anti-CD38 antibodies might offer relief for people suffering from moderate to severe forms of this challenging condition.
While one study emphasizes measuring symptom reduction over 26 weeks with a larger participant group, the other focuses on establishing safety and feasibility with ten participants over 40 weeks. Both trials require participants to have had the condition for at least two years with a clear triggering event, typically an infection.
These studies represent important steps in exploring new treatment options for a condition that currently has limited therapeutic choices and significantly impacts quality of life. The trials aim to provide valuable data on whether daratumumab can offer meaningful benefits to those living with this debilitating illness.
