UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009382 |
|---|---|
| Receipt number | R000011008 |
| Scientific Title | Exploratory Phase Trial of OCH-NCNP1 in Healthy Subjects and Patients with Multiple Sclerosis |
| Date of disclosure of the study information | 2012/11/23 |
| Last modified on | 2017/08/22 15:00:11 |
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Basic information
Public title
Exploratory Phase Trial of OCH-NCNP1 in Healthy Subjects and Patients with Multiple Sclerosis
Acronym
Exploratory Phase Trial of OCH-NCNP1
Scientific Title
Exploratory Phase Trial of OCH-NCNP1 in Healthy Subjects and Patients with Multiple Sclerosis
Scientific Title:Acronym
Exploratory Phase Trial of OCH-NCNP1
Region
| Japan |
Condition
Condition
Multiple Sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate safety of OCH-NCNP1, to elucidate its pharmacokinetics and to explore biomarkers related to its efficacy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse effects
Key secondary outcomes
(1) Exploration of biomarkers related to the efficacy
1) DNA microarray analysis
2) Frequency of NKT, NK and T cell subsets
3) Frequency of Th1/Th2/Th17 cells
4) Frequency of NK1/NK2 cells
5) Cytokine concentrations of the serum and cerebrospinal fluid
(2) Pharmacokinetics
(3) Expanded Disability Status Scale (EDSS) and Functional Scale (FS)
(4) MRI scan
1) Number of new T2-hyperintense lesions
2) Number of new T1-hypointense lesions
3) Number of Gd-enhancing lesions in T1-weighted images
4) FLAIR images
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
STEP1: healthy subjects
OCH-NCNP1 is orally administered once.
The dose is gradually increased from 0.3, 1, 3, 10, 30, 100, up to 300 mg.
STEP2: patients with multiple sclerosis
OCH-NCNP1 is orally administered once a week for 13 weeks to the 0.3mg dosage group and for 4 weeks to the 1mg or 3mg dosage group.
The dose is gradually increased from 0.3, 1, up to 3 mg.
Interventions/Control_2
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
Inclusion criteria for healthy subjects
(1) Provision of written informed consent to participate in this study
(2) 20=< Age < 50
(3) Women who promise to prevent conception for at least 90 days after the last administration
(4) 18.5 =< BMI < 25
Inclusion criteria for patients with multiple sclerosis
(1) Provision of written informed consent to participate in this study.
(2) Patients who are diagnosed relapsing remitting multiple sclerosis based on modified McDonald criteria in 2006.
(3) 20 =< Age < 65.
(4) Expanded Disability Status Scale =< 7.
(5) Women who promise to prevent conception for at least 90 days after the last administration
(6) Patients who are stable neurologically
Other protocol-defined inclusion criteria may apply.
Key exclusion criteria
Exclusion criteria for healthy subjects
1. Women who are pregnant or lactating
2. History of liver diseases
3. Positive for Beta-glucan or positive for QuantiFERON
4. History of HIV infection
5. History of HBV or HCV infection
6. Subjects who were administered with some medicine within two weeks
7. Compromised subjects
8. Inflammatory bowel disease
9. Subjects with prolongation of QT/QTc interval.
10. Smokers
Exclusion criteria for patients with relapsing remitting multiple sclerosis
1. Patients who diagnosed as Neuromyelitis Optica
2. Women who are pregnant or lactating
3. Patients who are allergic to Gd-contrast medium
4. History of liver diseases or liver transplantation
5. Liver dysfunction in the screening test and baseline physical examination
6. Beta-glucan-positive or QuantiFERON-positive
7. Positive for Anti-Aquaporin 4 antibody
8. History of HIV infection
9. History of HBV or HCV infection
10. Lymphocyte number < 800 /mm3 in peripheral blood
11. Compromised Patients
12. Inflammatory Bowel disease
13. Subjects with prolongation of QT/QTc interval.
14. Smokers
15. Bronchial Asthma
Other protocol-defined exclusion criteria may apply.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Okamoto |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Neurology, National Center Hospital
Zip code
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan
TEL
042-341-2711
okamotot@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Tsukamoto |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Clinical Research Promotion
Zip code
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan
TEL
042-341-2711
Homepage URL
chiken13@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
2012年9月20日（初回届）
Institutions
Institutions
国立精神･神経医療研究センター（東京都）/National Center of Neurology and Psychiatry（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 23 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 22 | Day |
Last modified on
| 2017 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011008
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