UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038903 |
|---|---|
| Receipt number | 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 | 2023/06/19 09:22:02 |
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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
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
Section of Clinical Research Suppor, Clinical Research and Education Promotion Division
Zip code
187-8551
Address
4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
TEL
0423412711
Homepage URL
ishizukatakami@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
国立精神・神経医療研究センター病院（東京都）、東京医科歯科大学病院（東京都）
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
30
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
Completed
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 | 12 | 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
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044202
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| Registered date | File name |
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