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Completed

NCT Number: NCT04211740

Phase II Clinical Trial of OCH-NCNP1

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) .

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Secondary Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Center of Neurology and Psychiatry

Tokyo, 187-8551, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCH-NCNP1

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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 outcomes

  1. annual relapse rate

    Time frame: Month 6

  2. Detection of asymptomatic

    Time frame: Month 6

  3. Expanded Disability Status Scale (EDSS) / Functional Scale (FS)

    Time frame: screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks

  4. Duration of sustained reduction in disability (SRD)

    Time frame: Month 6

  5. Change of MRI

    Time frame: Change from screening at Month 3 and 6

  6. Change of No evidence of disease activity (NEDA)

    Time frame: Change from screening at Month 3 and 6

Sponsors and collaborators

Lead sponsor

National Center of Neurology and Psychiatry, Japan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2019
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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