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Phase II Clinical Trial of OCH-NCNP1

Sponsor
National Center of Neurology and Psychiatry, Japan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04211740
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
32.8
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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) .

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis
Actual Study Start Date :
Dec 6, 2019
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: OCH-NCNP1 3 mg

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

Drug: Placebo
Placebo is supplied as granules and take orally once a week.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. annual relapse rate [Month 6]

  2. Detection of asymptomatic [Month 6]

  3. Expanded Disability Status Scale (EDSS) / Functional Scale (FS) [screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks]

  4. Duration of sustained reduction in disability (SRD) [Month 6]

  5. Change of MRI [Change from screening at Month 3 and 6]

  6. Change of No evidence of disease activity (NEDA) [Change from screening at Month 3 and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Center of Neurology and Psychiatry Tokyo Japan 187-8551

Sponsors and Collaborators

  • National Center of Neurology and Psychiatry, Japan

Investigators

  • Principal Investigator: Tomoko Okamoto, MD, National Center of Neurology and Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tomoko Okamoto, Medical director, National Center of Neurology and Psychiatry, Japan
ClinicalTrials.gov Identifier:
NCT04211740
Other Study ID Numbers:
  • OCH-NCNP1-02
First Posted:
Dec 26, 2019
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis

Study Results

No Results Posted as of Apr 11, 2022