NCT06952413View on ClinicalTrials.gov

Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 9, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

October 31, 2027

Conditions
Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Interventions
DRUG

Rituximab(Genetical Recombination)

Subjects will be assigned to the rituximab pre-treatment group or placebo pre-treatment group and will receive the study drug (rituximab actual or rituximab placebo) intravenously four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.

DRUG

Placebo

Subjects will be assigned to the rituximab pre-treatment group or placebo pre-treatment group and will receive the study drug (rituximab actual or rituximab placebo) intravenously four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.

Trial Locations (1)

187-8551

RECRUITING

National Center of Neurology and Psychiatry, Kodaira

All Listed Sponsors
lead

National Center of Neurology and Psychiatry, Japan

OTHER