Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
Conditions
Brief summary
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) .
Interventions
DRUGOCH-NCNP1
OCH-NCNP1 3mg is supplied as granules and take orally once a week.
DRUGPlacebo
Placebo is supplied as granules and take orally once a week.
Sponsors
National Center of Neurology and Psychiatry, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following 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
* Subject with MS patients meeting any of the following criteria must not be enrolled in the study: 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 27. Epilepsy Other protocol-defined
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Detection of asymptomatic | Month 6 |
| Expanded Disability Status Scale (EDSS) / Functional Scale (FS) | screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks |
| annual relapse rate | 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 |
| Duration of sustained reduction in disability (SRD) | Month 6 |
Countries
Japan
Outcome results
None listed