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

Sponsor
National Center of Neurology and Psychiatry, Japan
Study ID
NCT06952413
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab(Genetical Recombination) — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab(Genetical Recombination)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Improvement rate [ Time Frame: From Baseline to the end of treatment at 24 weeks ]

Central Contacts