Actively Recruiting
Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Led by National Center of Neurology and Psychiatry, Japan · Updated on 2025-04-30
30
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy and safety of rituximab on ME/CFS symptoms after administration to patients with myalgic encephalomyelitis/chronic fatigue syndrome will be compared in an exploratory, placebo-controlled, double-blind fashion. In the subsequent secondary evaluation period, subjects who received rituximab in the primary evaluation period will receive placebo, and the timing and duration of rituximab's effect will be explored throughout the entire evaluation period. Subjects who received placebo during the primary evaluation period will receive rituximab during the secondary evaluation period to explore changes in endpoints before and after switching from placebo to rituximab in the same subjects.
CONDITIONS
Official Title
Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ME/CFS meeting Canadian criteria by a physician
- ME/CFS severity score of 4 or higher on Performance Status (PS) classification
- Between 18 and 65 years of age at consent
- Able to be hospitalized from day before to day after administration for both evaluation periods
- Provided written consent to participate
You will not qualify if you...
- History of severe hypersensitivity or anaphylactic reactions to rituximab or mouse protein products
- Cardiopulmonary function judged not maintained by physician
- Fatigue not meeting ME/CFS diagnostic criteria
- Presence of other medical conditions causing symptoms
- Pregnant, lactating, or positive pregnancy test at enrollment
- Coexisting or prior malignant tumors (except basal cell carcinoma and cervical dysplasia)
- Severe immune system diseases (excluding thyroiditis and type 1 diabetes)
- History of systemic immunosuppressive therapy within 1 year or immunosuppressive drug treatment (except low-dose steroids 5 mg/day or less)
- Started alternative medicine therapies within 12 weeks before investigational drug treatment
- Severe endogenous (primary) depression
- Neutrophil count below 1.510^3/microliter or platelet count below 10.010^4/microliter
- Impaired renal function (serum creatinine over 1.5 times upper limit)
- Impaired hepatic function (bilirubin, AST, ALT over 1.5 times upper limit)
- Infection with HIV
- Positive for Hepatitis B surface antigen, antibodies, or Hepatitis C antibodies unless meeting specific monitoring conditions
- Unable to comply with study protocol
- Participated in other clinical trials with interventions within 16 weeks before consent
- Deemed inappropriate for participation by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Actively Recruiting
Research Team
T
Takami Ishizuka, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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