Overview
Phase II Clinical Trial of OCH-NCNP1
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2021-11-30
2021-11-30
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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