Efficacy and Safety of OCH-NCNP1 in patients with Relapsing Multiple Sclerosis

Phase 2

• Conditions: Multiple Sclerosis

• Registration Number: JPRN-UMIN000038903
• Lead Sponsor: ational Center of Neurology and Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-16
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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 with contraindications for 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 in the last 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 exclusion criteria may apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified