Relapsing-remitting Multiple SclerosisPhase 2NCT01742052
Dose-finding Study of MT-1303
A Phase 2 study testing MT-1303-Low, MT-1303-Middle and MT-1303-High in people with Relapsing-remitting Multiple Sclerosis, run by Tanabe Pharma Corporation at 18 sites in 18 countries.
Trial summary
The primary objectives of the study are: To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- MT-1303-Low, MT-1303-Middle and MT-1303-High
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Jan 2013to Oct 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- RRMS as defined by the revised McDonald criteria
- Evidence of recent MS activity defined as either:
- at least one documented relapse in the previous 12 months, OR
- a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR
- at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months
- Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
Who cannot join
- Primary progressive, secondary progressive or progressive relapsing MS at screening
- Disease duration >15 years combined with an EDSS score ≤2.0
- Relapse of MS during the Screening Period
- History or known presence of other neurological disorders likely to render the subject unsuitable for the study
- History of any of a list of pre-defined cardiovascular diseases
- History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study
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- Previous exposure to any sphingosine 1-phosphate receptor modulator
- Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation
- Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation
- Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation
- Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
- Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment
- Clinically significant electrocardiogram (ECG) findings.
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
Official title: A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple Sclerosis
The primary objectives of the study are:
- To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
- To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- MT-1303-Low, MT-1303-Middle, MT-1303-High, Placebo
- Keywords
- relapsing-remitting multiple sclerosis, RRMS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-1303-LowDrug
MT-1303-MiddleDrug
MT-1303-HighDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MT-1303-Low | Experimental | MT-1303-Low Dose Receives: Drug: MT-1303-Low |
| MT-1303-Middle | Experimental | MT-1303-Middle Dose Receives: Drug: MT-1303-Middle |
| MT-1303-High | Experimental | MT-1303-High Dose Receives: Drug: MT-1303-High |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of MRI Gd-enhanced T1-weighted lesions
Measured: Weeks 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionOct 2014
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 Relapsing-remitting Multiple SclerosisStudies 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
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742052
- Sponsor's protocol ID
- MT-1303-E04
- Status last verified
- Sep 2016
- First submitted
- 2 Dec 2012
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kappos L, Arnold DL, Bar-Or A, Camm J, Derfuss T, Kieseier BC, Sprenger T, Greenough K, Ni P, Harada T. Safety and efficacy of amiselimod in relapsing multiple sclerosis (MOMENTUM): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016 Oct;15(11):1148-59. doi: 10.1016/S1474-4422(16)30192-2. Epub 2016 Aug 16.
PubMed 27543447
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01742052
- Acronym / sponsor ID
- MT-1303-E04
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- relapsing-remitting multiple sclerosis, RRMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Dec 2012 (estimated)
- 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.
The primary objectives of the study are:
- To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
- To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT-1303-Low | Experimental | Drug: MT-1303-LowMT-1303-Low Dose |
| MT-1303-Middle | Experimental | Drug: MT-1303-MiddleMT-1303-Middle Dose |
| MT-1303-High | Experimental | Drug: MT-1303-HighMT-1303-High Dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- RRMS as defined by the revised McDonald criteria
- Evidence of recent MS activity defined as either:
- Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
Key exclusion criteria (13 listed)
- Primary progressive, secondary progressive or progressive relapsing MS at screening
- Disease duration >15 years combined with an EDSS score ≤2.0
- Relapse of MS during the Screening Period
- History or known presence of other neurological disorders likely to render the subject unsuitable for the study
- History of any of a list of pre-defined cardiovascular diseases
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 |
|---|---|---|
| MT-1303-Low | Drug | MT-1303-Low |
| MT-1303-Middle | Drug | MT-1303-Middle |
| MT-1303-High | Drug | MT-1303-High |
| Placebo | Drug | Placebo |
Primary outcome
The total number of MRI Gd-enhanced T1-weighted lesions
Time frame: Weeks 24
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 14 Sep 2016.
- Background: PubMed 27543447Kappos L, Arnold DL, Bar-Or A, Camm J, Derfuss T, Kieseier BC, Sprenger T, Greenough K, Ni P, Harada T. Safety and efficacy of amiselimod in relapsing multiple sclerosis (MOMENTUM): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016 Oct;15(11):1148-59. doi: 10.1016/S1474-4422(16)30192-2. Epub 2016 Aug 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-1303-Low, MT-1303-Middle and MT-1303-High in people with Relapsing-remitting Multiple Sclerosis, run by Tanabe Pharma Corporation at 18 sites in 18 countries.
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 6 inclusion and 13 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium, Bulgaria, Canada, Croatia, Czechia and 13 more countries. 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 total number of MRI Gd-enhanced T1-weighted lesions (time frame: Weeks 24). 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 NCT01742052, 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 14 Sep 2016.