Multiple Sclerosis, Relapsing-RemittingPhase 2NCT04211740
Phase II Clinical Trial of OCH-NCNP1
A Phase 2 study testing OCH-NCNP1 in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
Trial 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) . Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
- What is being tested?
- OCH-NCNP1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 6 Dec 2019to 31 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 20 =< Age < 65
- Promise to prevent conception for at least 90 days after the last administration
- Neurological stability has been confirmed by a neurologist
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis
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) .
- Being tested
- OCH-NCNP1, Placebo
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCH-NCNP1Drug
OCH-NCNP1 3mg is supplied as granules and take orally once a week.
PlaceboDrug
Placebo is supplied as granules and take orally once a week.
| Study group | Role | What they receive |
|---|---|---|
| OCH-NCNP1 3 mg | Active comparator | Not described Receives: Drug: OCH-NCNP1 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline
Measured: Change from screening at Month 6.
Secondary outcomes (6)
annual relapse rate
Measured: Month 6
Detection of asymptomatic
Measured: Month 6
Expanded Disability Status Scale (EDSS) / Functional Scale (FS)
Measured: screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks
Duration of sustained reduction in disability (SRD)
Measured: Month 6
Change of MRI
Measured: Change from screening at Month 3 and 6
Change of No evidence of disease activity (NEDA)
Measured: Change from screening at Month 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start6 Dec 2019
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center of Neurology and Psychiatry, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomoko Okamoto, National Center of Neurology and Psychiatry, Japan
- Investigators
- Tomoko Okamoto, MD, Principal investigator, National Center of Neurology and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211740
- Sponsor's protocol ID
- OCH-NCNP1-02
- Status last verified
- Nov 2023
- First submitted
- 17 Dec 2019
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okamoto T, Ishizuka T, Shimizu R, Asahina Y, Nakamura H, Shimizu Y, Nishida Y, Yokota T, Lin Y, Sato W, Yamamura T. Efficacy and Safety of the Natural Killer T Cell-Stimulatory Glycolipid OCH-NCNP1 for Patients With Relapsing Multiple Sclerosis: Protocol for a Randomized Placebo-Controlled Clinical Trial. JMIR Res Protoc. 2024 Jan 15;13:e46709. doi: 10.2196/46709.
PubMed 38224478
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04211740
- Acronym / sponsor ID
- OCH-NCNP1-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Center of Neurology and Psychiatry, JapanUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCH-NCNP1 3 mg | Active comparator | Drug: OCH-NCNP1 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria:
Key exclusion criteria (28 listed)
- Subject with MS patients meeting any of the following criteria must not be enrolled in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCH-NCNP1OCH-NCNP1 3mg is supplied as granules and take orally once a week. | Drug | OCH-NCNP1 3 mg |
| PlaceboPlacebo is supplied as granules and take orally once a week. | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
annual relapse rate
Time frame: Month 6
Detection of asymptomatic
Time frame: Month 6
Expanded Disability Status Scale (EDSS) / Functional Scale (FS)
Time frame: screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks
Duration of sustained reduction in disability (SRD)
Time frame: Month 6
Change of MRI
Time frame: Change from screening at Month 3 and 6
Change of No evidence of disease activity (NEDA)
Time frame: Change from screening at Month 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 38224478Okamoto T, Ishizuka T, Shimizu R, Asahina Y, Nakamura H, Shimizu Y, Nishida Y, Yokota T, Lin Y, Sato W, Yamamura T. Efficacy and Safety of the Natural Killer T Cell-Stimulatory Glycolipid OCH-NCNP1 for Patients With Relapsing Multiple Sclerosis: Protocol for a Randomized Placebo-Controlled Clinical Trial. JMIR Res Protoc. 2024 Jan 15;13:e46709. doi: 10.2196/46709.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoko Okamoto, MD principal investigator
National Center of Neurology and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OCH-NCNP1 in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.