Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2019-12-06
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OCH-NCNP1 3 mg
OCH-NCNP1
OCH-NCNP1 3mg is supplied as granules and take orally once a week.
Placebo
Placebo
Placebo is supplied as granules and take orally once a week.
Interventions
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OCH-NCNP1
OCH-NCNP1 3mg is supplied as granules and take orally once a week.
Placebo
Placebo is supplied as granules and take orally once a week.
Eligibility Criteria
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Inclusion Criteria
1. Provision of written informed consent to participate in this study
2. Patients diagnosed as relapsing remitting multiple sclerosis based on modified McDonald criteria in 2017
3. Relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment
4. Have at least one T2 lesion on MRI scans at screening
5. EDSS less than or equal to 7
6. 20 =\< Age \< 65
7. Promise to prevent conception for at least 90 days after the last administration
8. Neurological stability has been confirmed by a neurologist
Exclusion Criteria
1. Diagnosed as Neuromyelitis Optica
2. Women who are pregnant or lactating
3. Patients who is prohibited MRI
4. Patients who are allergic to Gd-contrast medium
5. History of liver diseases or liver transplantation
6. Liver dysfunction in the screening test and baseline physical examination
7. History of cancer past five years
8. Negative for herpes zoster virus antibody
9. Positive for Syphilis serum reaction
10. Positive for Beta-glucan or positive for T-spot
11. Positive for Anti-Aquaporin 4 antibody
12. History of HIV infection
13. History of HBV or HCV infection
14. History of Transplantation
15. Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication.
16. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication
17. Lymphocyte number \< 600 /mm3 in peripheral blood
18. Current diagnosed or suspected infectious diseases
19. Compromised Patients
20. Inflammatory Bowel disease
21. Subjects with prolongation of QT/QTc interval
22. History or have risk of torsade de pointes
23. Taking the medicine which has risk of prolongation of QT/QTc interval
24. History of severe allergy of medicine or food
25. History or current of drug/ alcohol addiction
26. Bronchial Asthma
20 Years
65 Years
ALL
No
Sponsors
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National Center of Neurology and Psychiatry, Japan
OTHER
Responsible Party
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Tomoko Okamoto
Medical director
Principal Investigators
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Tomoko Okamoto, MD
Role: PRINCIPAL_INVESTIGATOR
National Center of Neurology and Psychiatry
Locations
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National Center of Neurology and Psychiatry
Tokyo, , Japan
Countries
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References
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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.
Other Identifiers
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OCH-NCNP1-02
Identifier Type: -
Identifier Source: org_study_id
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