Multiple Sclerosis
Conditions
Interventions
STEP1: healthy subjects OCH-NCNP1 is orally administered once. The dose is gradually increased from 0.3, 1, 3, 10, 30, 100, up to 300 mg. STEP2: patients with multiple sclerosis OCH-NCNP1 is ora
Sponsors
National Center of Neurology and Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy subjects (1) Provision of written informed consent to participate in this study (2) 20=< Age < 50 (3) Women who promise to prevent conception for at least 90 days after the last administration (4) 18.5 =< BMI < 25 Inclusion criteria for patients with multiple sclerosis (1) Provision of written informed consent to participate in this study. (2) Patients who are diagnosed relapsing remitting multiple sclerosis based on modified McDonald criteria in 2006. (3) 20 =< Age < 65. (4) Expanded Disability Status Scale =< 7. (5) Women who promise to prevent conception for at least 90 days after the last administration (6) Patients who are stable neurologically Other protocol-defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy subjects 1. Women who are pregnant or lactating 2. History of liver diseases 3. Positive for Beta-glucan or positive for QuantiFERON 4. History of HIV infection 5. History of HBV or HCV infection 6. Subjects who were administered with some medicine within two weeks 7. Compromised subjects 8. Inflammatory bowel disease 9. Subjects with prolongation of QT/QTc interval. 10. Smokers Exclusion criteria for patients with relapsing remitting multiple sclerosis 1. Patients who diagnosed as Neuromyelitis Optica 2. Women who are pregnant or lactating 3. Patients who are allergic to Gd-contrast medium 4. History of liver diseases or liver transplantation 5. Liver dysfunction in the screening test and baseline physical examination 6. Beta-glucan-positive or QuantiFERON-positive 7. Positive for Anti-Aquaporin 4 antibody 8. History of HIV infection 9. History of HBV or HCV infection 10. Lymphocyte number < 800 /mm3 in peripheral blood 11. Compromised Patients 12. Inflammatory Bowel disease 13. Subjects with prolongation of QT/QTc interval. 14. Smokers 15. Bronchial Asthma Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Exploration of biomarkers related to the efficacy 1) DNA microarray analysis 2) Frequency of NKT, NK and T cell subsets 3) Frequency of Th1/Th2/Th17 cells 4) Frequency of NK1/NK2 cells 5) Cytokine concentrations of the serum and cerebrospinal fluid (2) Pharmacokinetics (3) Expanded Disability Status Scale (EDSS) and Functional Scale (FS) (4) MRI scan 1) Number of new T2-hyperintense lesions 2) Number of new T1-hypointense lesions 3) Number of Gd-enhancing lesions in T1-weighted images 4) FLAIR images | — |
Countries
Japan
Contacts
Public ContactSachiko Tsukamoto
National Center of Neurology and Psychiatry Department of Clinical Research Promotion
Outcome results
None listed