Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)Phase 2NCT06952413
Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
A Phase 2 study testing Rituximab(Genetical Recombination) in people with Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- What is being tested?
- Rituximab(Genetical Recombination)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 9 Apr 2025to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with ME/CFS who meet the Canadian criteria by a physician.
- Patients with a severity score of 4 or higher on the Performance Status (PS) based ME/CFS severity classification by the Ministry of Health, Labour and Welfare Research Group
- Patients who are between 18 and 65 years of age at the time of obtaining written consent
- Patients who can be hospitalized (hospitalized from the day before administration and discharged the day after administration) at the time of the first dose of each of the primary and secondary evaluation periods
- Patients whose written consent has been obtained
Who cannot join
- Patients with a history of severe hypersensitivity or anaphylactic reactions to components of rituximab or products derived from mouse protein
- Patients whose cardiopulmonary function is judged by the treating physician to be not maintained
- Patients complaining of fatigue that does not meet the diagnostic criteria for ME/CFS
- Patients found to have other medical conditions that may cause symptoms
- Patients who are pregnant, lactating, or have a positive pregnancy test (serum human chorionic gonadotropin test) at the time of enrollment
- Patients with coexisting or pre-existing malignant tumors (excluding basal cell carcinoma of the skin and cervical dysplasia)
Show all 21Show fewer
- Patients with coexisting or pre-existing severe immune system diseases (excluding autoimmune diseases such as thyroiditis and type 1 diabetes)
- Patients with a history of systemic immunosuppressive therapy (e.g., immunoglobulin therapy, azathioprine, cyclosporine, mycophenolate mofetil, etc.) within 1 year, a history of receiving drugs such as monoclonal antibodies acting on the immune system (e.g., anti-CD20 antibody products including rituximab), or a history of comorbidities requiring treatment with immunosuppressive drugs Patients with comorbidities requiring treatment with immunosuppressive agents (excluding treatment with low-dose steroids of 5 mg /day or less)
- Patients who have started alternative medicine (reference: acupuncture, moxibustion, and Japanese warm therapy) within 12 weeks prior to the start of treatment with the investigational drug.
- Patients with severe endogenous (primary) depression
- Patients with a neutrophil count <1.5*103/microliter and platelet count <10.0*104/microliter on blood test
- Patients with impaired renal function (serum creatinine level > 1.5 times the upper limit of the reference value at the institution)
- Patients with impaired hepatic function (serum bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) levels exceeding 1.5 times the upper limit of the reference value of the institution)
- Patients infected with Human Immunodeficiency Virus (HIV)
- Patients who test positive for at least one of Hepatitis B surface (HBs) antigen, HBs antibody, Hepatitis B core (HBc) antibody, or Hepatitis C virus (HCV) antibody.
- However, patients who meet the following conditions (1) and (2) may be registered.
- Patients who are positive for HBs or HBc antibodies and whose HBV-DNA quantification is confirmed to be negative (less than detection sensitivity) and for whom appropriate monitoring, etc. can be conducted in accordance with the Guidelines for Hepatitis B Treatment edited by the Japan Society of Hepatology.
- For patients with positive HCV antibody, when HCV-RNA quantification is negative (less than detection sensitivity)
- Patients who do not have the ability to comply with the study protocol
- Patients who have participated in other clinical trials or clinical studies (except for observational studies without intervention) within 16 weeks prior to obtaining consent
- Other patients who are judged by the investigator or subinvestigator (hereinafter referred to as investigator) to be inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
Takami Ishizuka, PhD, +81-42-341-2711, tmc-crso@ncnp.go.jp
Tomoko Okamoto, MD
About this study
Official title: An Exploratory, Placebo-controlled, Double-blind, Phase II Study of the Efficacy and Safety for Rituximab (Genetical Recombination) in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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.
Read the detailed description
The efficacy and safety of rituximab (genetical recombination), a CD20 antibody, 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.
- Being tested
- Rituximab(Genetical Recombination), Placebo
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Rituximab(Genetical Recombination) | Active comparator | Not described Receives: Drug: Rituximab(Genetical Recombination) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate
Percentage of cases in which the severity score of ME/CFS based on PS by the MHLW research group improved by 1 or more compared to that before the start of study drug administration (week 0)
Measured: From Baseline to the end of treatment at 24 weeks
Secondary outcomes (29)
Percentage of patients whose MHLW-PS-based ME/CFS severity score improved by 1 or more at each evaluation point (improvement rate) compared to that before the start of treatment with the investigational drug (week 0).
Measured: At 4-week intervals from Baseline up to Week 48
The amount of change in the severity score of ME/CFS based on PS by the MHLW Research Group at each assessment point from that before the start of treatment with the investigational drug (week 0)
Measured: At 4-week intervals from Baseline up to Week 48
Proportion of awake time spent in supine position (%),Proportion of awake time spent in sitting position (%)
Changes in proportions will be aggregated.
Measured: At 4-week intervals from Baseline up to Week 48
Duration of standing and activity (hours)
Changes in time will be aggregated.
Measured: At 4-week intervals from Baseline up to Week 48
Fatigue during rest and lying position
Patients will be asked to report the level of fatigue they feel even while lying down, and changes in their fatigue levels will be aggregated.
Measured: At 4-week intervals from Baseline up to Week 48
Records on exertion and Post-Exertional Malaise (PEM)
Patients will be asked to describe the specific activities they perform and the exhaustion they experience afterward, and a summary table will be created.
Measured: At 4-week intervals from Baseline up to Week 48
Assessment of fatigue during physical activity
Patients will be asked to report the level of fatigue they experience during physical activity in daily life, and changes in fatigue levels will be aggregated.
Measured: At 4-week intervals from Baseline up to Week 48
Evaluation based on Fatigue Score
Patients will be asked to complete the Fatigue Score questionnaire, and changes in the score will be aggregated.
Measured: At 2-week intervals from Baseline up to Week 48
SF-36
Changes in scores obtained from the SF-36 questionnaire will be assessed to evaluate patients' quality of life.
Measured: At 12-week intervals from Baseline up to Week 48
COMPASS31
Changes in scores obtained from the COMPASS31 questionnaire will be assessed to evaluate patients' autonomic symptoms.
Measured: At 12-week intervals from Baseline up to Week 48
Pittsburgh Sleep Quality Index (PSQI)
Changes in scores obtained from the PSQI questionnaire will be assessed to evaluate patients' sleep quality.
Measured: At 12-week intervals from Baseline up to Week 48
Pain intensity
Pain intensity will be assessed using the Visual Analogue Scale (VAS)
Measured: At 12-week intervals from Baseline up to Week 48
Grip strength
Patients' grip strength will be measured, and changes in the measurements will be aggregated.
Measured: At 12-week intervals from Baseline up to Week 48
Analysis of the gut microbiota
samples collected from patients will be analyzed, and the composition of the gut microbiota will be aggregated.
Measured: At 24-week intervals from Baseline up to Week 48
Brain imaging evaluation (Magnetic Resonance Imaging (MRI) of the head, Single Photon Emission Computed Tomography (SPECT) of cerebral blood flow)
Findings from imaging will be aggregated.
Measured: At 24-week intervals from Baseline up to Week 48
Immune biomarker analysis (qPCR)
qPCR will be measured, and changes in their levels will be aggregated.
Measured: At 24-week intervals from Baseline up to Week 48
Immune biomarker analysis (anti-autonomic receptor antibody analysis)
Quantify the level of anti-autonomic receptor antibodies will be measured, and changes in their levels will be aggregated.
Measured: At 24-week intervals from Baseline up to Week 48
Immune biomarker analysis (immune cell subfractionation analysis)
The subsets of immune cells will be measured, and changes in the levels will be aggregated.
Measured: At 24-week intervals from Baseline up to Week 48
Metabolome analysis
A detailed characterization of the patients' metabolome at baseline will be conducted.
Measured: At Baseline
Adverse events
The number of adverse events will be aggregated.
Measured: From Baseline up to Week 48
Vital signs (body temperature)
Summary statistics of vital signs will be calculated to monitor changes over time.
Measured: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48
Vital signs (blood pressure)
Summary statistics of vital signs will be calculated to monitor changes over time.
Measured: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48
Vital signs (pulse rate)
Summary statistics of vital signs will be calculated to monitor changes over time.
Measured: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48
Serum immunoglobulins (IgG)
Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.
Measured: At 4-week intervals from Baseline up to Week 48
Serum immunoglobulins (IgM)
Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.
Measured: At 4-week intervals from Baseline up to Week 48
Serum immunoglobulins (IgA)
Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.
Measured: At 4-week intervals from Baseline up to Week 48
Rituximab concentration of the blood plasma
Rituximab concentration of the blood plasma
Measured: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 12, 24, 25, 26, 27, 28, 36, and 48
Blood drug concentration Anti-Drug Antibody (ADA)
Summary statistics of ADA will be calculated to monitor changes over time.
Measured: Assessments will be conducted at baseline and at Weeks 4, 12, 24, 28, 36, and 48.
B cells (CD19/CD20 positive cells) and T cells (CD3/CD4/CD8 positive cells)
Summary statistics of B cells and T cells will be calculated to monitor changes over time.
Measured: Assessments will be conducted at baseline and at Weeks 1, 12, 24, 25, 36, and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start9 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center of Neurology and Psychiatry, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomoko Okamoto, MD, Principal investigator, National Center of Neurology and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952413
- Sponsor's protocol ID
- IDEC-C2B8-MC
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Placebo-controlled, Double-blind, Phase II Study of the Efficacy and Safety for Rituximab (Genetical Recombination) in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT06952413
- Acronym / sponsor ID
- IDEC-C2B8-MC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Center of Neurology and Psychiatry, JapanUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The efficacy and safety of rituximab (genetical recombination), a CD20 antibody, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab(Genetical Recombination) | Active comparator | Drug: Rituximab(Genetical Recombination) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with ME/CFS who meet the Canadian criteria by a physician.
- Patients with a severity score of 4 or higher on the Performance Status (PS) based ME/CFS severity classification by the Ministry of Health, Labour and Welfare Research Group
- Patients who are between 18 and 65 years of age at the time of obtaining written consent
- Patients who can be hospitalized (hospitalized from the day before administration and discharged the day after administration) at the time of the first dose of each of the primary and secondary evaluation periods
- Patients whose written consent has been obtained
Key exclusion criteria (21 listed)
- Patients with a history of severe hypersensitivity or anaphylactic reactions to components of rituximab or products derived from mouse protein
- Patients whose cardiopulmonary function is judged by the treating physician to be not maintained
- Patients complaining of fatigue that does not meet the diagnostic criteria for ME/CFS
- Patients found to have other medical conditions that may cause symptoms
- Patients who are pregnant, lactating, or have a positive pregnancy test (serum human chorionic gonadotropin test) at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Rituximab(Genetical Recombination) |
| PlaceboSubjects 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 |
Primary outcome
Improvement rate
Time frame: From Baseline to the end of treatment at 24 weeks
Percentage of cases in which the severity score of ME/CFS based on PS by the MHLW research group improved by 1 or more compared to that before the start of study drug administration (week 0)
29 secondary outcomes
Percentage of patients whose MHLW-PS-based ME/CFS severity score improved by 1 or more at each evaluation point (improvement rate) compared to that before the start of treatment with the investigational drug (week 0).
Time frame: At 4-week intervals from Baseline up to Week 48
The amount of change in the severity score of ME/CFS based on PS by the MHLW Research Group at each assessment point from that before the start of treatment with the investigational drug (week 0)
Time frame: At 4-week intervals from Baseline up to Week 48
Proportion of awake time spent in supine position (%),Proportion of awake time spent in sitting position (%)
Time frame: At 4-week intervals from Baseline up to Week 48
Duration of standing and activity (hours)
Time frame: At 4-week intervals from Baseline up to Week 48
Fatigue during rest and lying position
Time frame: At 4-week intervals from Baseline up to Week 48
Records on exertion and Post-Exertional Malaise (PEM)
Time frame: At 4-week intervals from Baseline up to Week 48
Assessment of fatigue during physical activity
Time frame: At 4-week intervals from Baseline up to Week 48
Evaluation based on Fatigue Score
Time frame: At 2-week intervals from Baseline up to Week 48
SF-36
Time frame: At 12-week intervals from Baseline up to Week 48
COMPASS31
Time frame: At 12-week intervals from Baseline up to Week 48
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At 12-week intervals from Baseline up to Week 48
Pain intensity
Time frame: At 12-week intervals from Baseline up to Week 48
Grip strength
Time frame: At 12-week intervals from Baseline up to Week 48
Analysis of the gut microbiota
Time frame: At 24-week intervals from Baseline up to Week 48
Brain imaging evaluation (Magnetic Resonance Imaging (MRI) of the head, Single Photon Emission Computed Tomography (SPECT) of cerebral blood flow)
Time frame: At 24-week intervals from Baseline up to Week 48
Immune biomarker analysis (qPCR)
Time frame: At 24-week intervals from Baseline up to Week 48
Immune biomarker analysis (anti-autonomic receptor antibody analysis)
Time frame: At 24-week intervals from Baseline up to Week 48
Immune biomarker analysis (immune cell subfractionation analysis)
Time frame: At 24-week intervals from Baseline up to Week 48
Metabolome analysis
Time frame: At Baseline
Adverse events
Time frame: From Baseline up to Week 48
Vital signs (body temperature)
Time frame: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48
Vital signs (blood pressure)
Time frame: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48
Vital signs (pulse rate)
Time frame: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48
Serum immunoglobulins (IgG)
Time frame: At 4-week intervals from Baseline up to Week 48
Serum immunoglobulins (IgM)
Time frame: At 4-week intervals from Baseline up to Week 48
Serum immunoglobulins (IgA)
Time frame: At 4-week intervals from Baseline up to Week 48
Rituximab concentration of the blood plasma
Time frame: Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 12, 24, 25, 26, 27, 28, 36, and 48
Blood drug concentration Anti-Drug Antibody (ADA)
Time frame: Assessments will be conducted at baseline and at Weeks 4, 12, 24, 28, 36, and 48.
B cells (CD19/CD20 positive cells) and T cells (CD3/CD4/CD8 positive cells)
Time frame: Assessments will be conducted at baseline and at Weeks 1, 12, 24, 25, 36, and 48.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomoko Okamoto, MD principal investigator
National Center of Neurology and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab(Genetical Recombination) in people with Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takami Ishizuka, PhD (+081-42-341-2711, tmc-crso@ncnp.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate (time frame: From Baseline to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.