Phase II Clinical Trial of OCH-NCNP1
Phase 2
Completed
- Conditions
- Multiple Sclerosis, Secondary ProgressiveMultiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Placebo
- Registration Number
- NCT04211740
- Lead Sponsor
- National Center of Neurology and Psychiatry, Japan
- 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) .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - OCH-NCNP1 3 mg OCH-NCNP1 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Change of MRI Change from screening at Month 3 and 6 Duration of sustained reduction in disability (SRD) Month 6 Change of No evidence of disease activity (NEDA) Change from screening at Month 3 and 6 Expanded Disability Status Scale (EDSS) / Functional Scale (FS) screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks annual relapse rate Month 6 Detection of asymptomatic Month 6
Trial Locations
- Locations (1)
National Center of Neurology and Psychiatry
🇯🇵Tokyo, Japan
National Center of Neurology and Psychiatry🇯🇵Tokyo, Japan