Phase II Clinical Trial of OCH-NCNP1

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211740
• Other study ID #: OCH-NCNP1-02
• Status: Completed
• Phase: Phase 2
• Start date: December 6, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2023
• Source: National Center of Neurology and Psychiatry, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Secondary Progressive
• Sclerosis

Intervention

Drug:
• OCH-NCNP1
OCH-NCNP1 3mg is supplied as granules and take orally once a week.
• Placebo
Placebo is supplied as granules and take orally once a week.

Locations

Country	Name	City	State
Japan	National Center of Neurology and Psychiatry	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	annual relapse rate		Month 6
Secondary	Detection of asymptomatic		Month 6
Secondary	Expanded Disability Status Scale (EDSS) / Functional Scale (FS)		screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks
Secondary	Duration of sustained reduction in disability (SRD)		Month 6
Secondary	Change of MRI		Change from screening at Month 3 and 6
Secondary	Change of No evidence of disease activity (NEDA)		Change from screening at Month 3 and 6