Phase II Clinical Trial of OCH-NCNP1

NCT04211740 | Completed Phase 2

• 1 other identifier: OCH-NCNP1-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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) .

Conditions

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

Outcome Measures

Primary Outcomes (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 Outcomes (6)

• annual relapse rate

  Month 6

• Detection of asymptomatic

  Month 6

• Expanded Disability Status Scale (EDSS) / Functional Scale (FS)

  screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks

• Duration of sustained reduction in disability (SRD)

  Month 6

• Change of MRI

  Change from screening at Month 3 and 6

Study Arms (2)

OCH-NCNP1 3 mg

ACTIVE COMPARATOR

Drug: OCH-NCNP1

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OCH-NCNP1 DRUG

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

OCH-NCNP1 3 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• =\< Age \< 65
• Promise to prevent conception for at least 90 days after the last administration
• Neurological stability has been confirmed by a neurologist

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center of Neurology and Psychiatry, Japan: lead

Study Sites (1)

National Center of Neurology and Psychiatry

Tokyo, 187-8551, Japan

Location

Related Publications (1)

• Okamoto T, Ishizuka T, Shimizu R, Asahina Y, Nakamura H, Shimizu Y, Nishida Y, Yokota T, Lin Y, Sato W, Yamamura T. Efficacy and Safety of the Natural Killer T Cell-Stimulatory Glycolipid OCH-NCNP1 for Patients With Relapsing Multiple Sclerosis: Protocol for a Randomized Placebo-Controlled Clinical Trial. JMIR Res Protoc. 2024 Jan 15;13:e46709. doi: 10.2196/46709.

  PMID: 38224478 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomoko Okamoto, MD

  National Center of Neurology and Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 26, 2019
• Study Start: December 6, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)