Printed from Voxsanity (voxsanity.com.au) — NCT06952413 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Chronic Fatigue Syndrome
Phase 2 Chronic Fatigue Syndrome Trial, Recruiting
NCT06952413
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with ME/CFS by a doctor using a specific set of diagnostic standards called the Canadian Criteria
- Your ME/CFS has been rated at severity level 4 or higher on a standard severity scale used in Japan
- You are between 18 and 65 years old at the time of signing the consent form
- You are able to stay overnight in hospital around the time of each main treatment dose (admitted the day before and discharged the day after)
- You are willing and able to give written consent to take part
Who may not be able to join:
- You have had a severe allergic or anaphylactic reaction in the past to rituximab or to products made from mouse proteins
- Your doctor has concerns about your heart or lung function not being well maintained
- Your fatigue symptoms do not fully meet the official diagnostic criteria for ME/CFS
- You have another medical condition that could be causing your symptoms
- You are pregnant, breastfeeding, or have a positive pregnancy blood test at the time of enrollment
- You have or have previously had cancer (except for a specific type of skin cancer called basal cell carcinoma, or cervical dysplasia)
- You have or have previously had a serious immune system disease (not including autoimmune conditions such as thyroid disease or type 1 diabetes)
- You have received immune-suppressing treatments or certain antibody-based medicines (including rituximab) within the past year, or you currently have a condition that requires such treatments (low-dose steroids at 5mg/day or less may be acceptable — confirm with trial site)
- You have started certain alternative therapies such as acupuncture, moxibustion, or Japanese warm therapy within 12 weeks before starting the trial treatment
- You have severe primary (endogenous) depression
- Your blood test shows your white blood cell count (neutrophils) or platelet count is below a certain level (confirm with trial site)
- Your kidneys are not functioning well, based on a specific blood test result (confirm with trial site)
- Your liver is not functioning well, based on specific blood test results (confirm with trial site)
- You are infected with HIV
- You have tested positive for certain hepatitis B or hepatitis C markers — though in some specific circumstances, with negative virus levels and proper monitoring, participation may still be possible (confirm with trial site)
- You are not able to follow the rules and schedule of the study
- You have taken part in another clinical trial or intervention study within the 16 weeks before signing the consent form
- The trial doctors consider you unsuitable to participate for any other reason
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Tomoko Okamoto, MD, National Center of Neurology and Psychiatry
Phone: +081-42-341-2711
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
National Center of Neurology and Psychiatry, Japan
Registry
ClinicalTrials.gov
Start date
9 April 2025
Est. completion
30 September 2026
Where this trial is recruiting
🇯🇵 Japan
Primary endpoints
Improvement rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.