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Phase II Clinical Trial of OCH-NCNP1

Primary Purpose

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

Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OCH-NCNP1
Placebo
Sponsored by
National Center of Neurology and Psychiatry, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Center of Neurology and Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OCH-NCNP1 3 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline

Secondary Outcome Measures

annual relapse rate
Detection of asymptomatic
Expanded Disability Status Scale (EDSS) / Functional Scale (FS)
Duration of sustained reduction in disability (SRD)
Change of MRI
Change of No evidence of disease activity (NEDA)

Full Information

First Posted
December 17, 2019
Last Updated
September 28, 2022
Sponsor
National Center of Neurology and Psychiatry, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT04211740
Brief Title
Phase II Clinical Trial of OCH-NCNP1
Official Title
Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center of Neurology and Psychiatry, Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCH-NCNP1 3 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OCH-NCNP1
Intervention Description
OCH-NCNP1 3mg is supplied as granules and take orally once a week.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is supplied as granules and take orally once a week.
Primary Outcome Measure Information:
Title
The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline
Time Frame
Change from screening at Month 6.
Secondary Outcome Measure Information:
Title
annual relapse rate
Time Frame
Month 6
Title
Detection of asymptomatic
Time Frame
Month 6
Title
Expanded Disability Status Scale (EDSS) / Functional Scale (FS)
Time Frame
screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks
Title
Duration of sustained reduction in disability (SRD)
Time Frame
Month 6
Title
Change of MRI
Time Frame
Change from screening at Month 3 and 6
Title
Change of No evidence of disease activity (NEDA)
Time Frame
Change from screening at Month 3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria: Provision of written informed consent to participate in this study Patients diagnosed as relapsing remitting multiple sclerosis based on modified McDonald criteria in 2017 Relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment Have at least one T2 lesion on MRI scans at screening EDSS less than or equal to 7 20 =< Age < 65 Promise to prevent conception for at least 90 days after the last administration 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: Diagnosed as Neuromyelitis Optica Women who are pregnant or lactating Patients who is prohibited MRI Patients who are allergic to Gd-contrast medium History of liver diseases or liver transplantation Liver dysfunction in the screening test and baseline physical examination History of cancer past five years Negative for herpes zoster virus antibody Positive for Syphilis serum reaction Positive for Beta-glucan or positive for T-spot Positive for Anti-Aquaporin 4 antibody History of HIV infection History of HBV or HCV infection History of Transplantation Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication Lymphocyte number < 600 /mm3 in peripheral blood Current diagnosed or suspected infectious diseases Compromised Patients Inflammatory Bowel disease Subjects with prolongation of QT/QTc interval History or have risk of torsade de pointes Taking the medicine which has risk of prolongation of QT/QTc interval History of severe allergy of medicine or food History or current of drug/ alcohol addiction Bronchial Asthma Epilepsy Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoko Okamoto, MD
Organizational Affiliation
National Center of Neurology and Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase II Clinical Trial of OCH-NCNP1

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