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This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary progressive mltiple sclerosis (SPMS) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCH-NCNP1 3 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCH-NCNP1 | Drug | OCH-NCNP1 3mg is supplied as granules and take orally once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline | Change from screening at Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| annual relapse rate | Month 6 | |
| Detection of asymptomatic | Month 6 | |
| Expanded Disability Status Scale (EDSS) / Functional Scale (FS) |
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Inclusion Criteria:
Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria:
Exclusion Criteria:
Subject with MS patients meeting any of the following criteria must not be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Okamoto, MD | National Center of Neurology and Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Neurology and Psychiatry | Tokyo | 187-8551 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38224478 | Derived | Okamoto T, Ishizuka T, Shimizu R, Asahina Y, Nakamura H, Shimizu Y, Nishida Y, Yokota T, Lin Y, Sato W, Yamamura T. Efficacy and Safety of the Natural Killer T Cell-Stimulatory Glycolipid OCH-NCNP1 for Patients With Relapsing Multiple Sclerosis: Protocol for a Randomized Placebo-Controlled Clinical Trial. JMIR Res Protoc. 2024 Jan 15;13:e46709. doi: 10.2196/46709. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| Placebo |
| Drug |
Placebo is supplied as granules and take orally once a week. |
|
| screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks |
| Duration of sustained reduction in disability (SRD) | Month 6 |
| Change of MRI | Change from screening at Month 3 and 6 |
| Change of No evidence of disease activity (NEDA) | Change from screening at Month 3 and 6 |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |