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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038903
Receipt No. R000044202
Scientific Title Efficacy and Safety of OCH-NCNP1 in patients with Relapsing Multiple Sclerosis
Date of disclosure of the study information 2019/12/16
Last modified on 2020/08/03

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Basic information
Public title Efficacy and Safety of OCH-NCNP1 in patients with Relapsing Multiple Sclerosis
Acronym Phase II clinical trial of OCH-NCNP1
Scientific Title Efficacy and Safety of OCH-NCNP1 in patients with Relapsing Multiple Sclerosis
Scientific Title:Acronym Phase II clinical trial of OCH-NCNP1
Region
Japan

Condition
Condition Multiple Sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in subjects with relapsing multiple sclerosis patients (including both relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS)).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline
Key secondary outcomes 1. Annual relapse rate (ARR)
2. Duration of relapse free state
3. Expanded Disability Status Scale (EDSS) and Functional Scale (FS)
4. Duration of sustained reduction of disability (SRD)
5. MRI
6. No evidence of disease activity (NEDA)
7. Biomarker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 OCH-NCNP1 3 mg
Interventions/Control_2 Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key 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
Key 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 with contraindications for 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 in the last 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomoko
Middle name
Last name Okamoto
Organization National Center of Neurology and Psychiatry
Division name Department of Neurology, National Center Hospital
Zip code 187-8551
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
TEL 0423412711
Email okamotot@ncnp.go.jp

Public contact
Name of contact person
1st name Takami
Middle name
Last name Ishizuka
Organization National Center of Neurology and Psychiatry
Division name Clinical Research Suppor Office, Translaional Medical Center
Zip code 187-8551
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
TEL 0423412711
Homepage URL
Email ishizukatakami@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Neurology and Psychiatry
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
Tel 0423412711
Email irb-office@ncnp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 07 Month 17 Day
Date of IRB
2019 Year 07 Month 17 Day
Anticipated trial start date
2019 Year 12 Month 04 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 16 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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