Phase II Clinical Trial of OCH-NCNP1

• Status: Enrolling by invitation
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center of Neurology and Psychiatry, Japan

Criteria

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 exclusion criteria may apply