Relapsing-remitting Multiple SclerosisPhase 2NCT01890655
Extension 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 17 sites in 17 countries.
Trial summary
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS). 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?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 17 sitesin 17 countries
- Study dates
- Aug 2013to Mar 2016
- 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
- Completion of the 24-week treatment period in MT-1303-E04 as per protocol
- Able to provide written informed consent and to comply with the requirements of the protocol
- For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
Who cannot join
- Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
- Newly diagnosed diabetes mellitus during MT-1303-E04
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
About this study
Official title: A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- MT-1303-Low, MT-1303-Middle, MT-1303-High
- 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
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
Adverse Events
Measured: Month 18
Secondary outcomes (2)
Clinical efficacy
Annualised relapse rate(ARR)
Measured: Month 18
Magnetic Resonance Imaging (MRI)
Change and percent change in brain volume at EOT
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludwig Kappos, MD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890655
- Sponsor's protocol ID
- MT-1303-E05
- Status last verified
- Apr 2016
- First submitted
- 26 Jun 2013
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study
- ClinicalTrials.gov ID
- NCT01890655
- Acronym / sponsor ID
- MT-1303-E05
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- relapsing-remitting multiple sclerosis, RRMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Jul 2013 (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.
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Completion of the 24-week treatment period in MT-1303-E04 as per protocol
- Able to provide written informed consent and to comply with the requirements of the protocol
- For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
Key exclusion criteria (2 listed)
- Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
- Newly diagnosed diabetes mellitus during MT-1303-E04
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 |
Primary outcome
Safety assessments
Time frame: Month 18
Adverse Events
2 secondary outcomes
Clinical efficacy
Time frame: Month 18
Magnetic Resonance Imaging (MRI)
Time frame: Month 18
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 11 Apr 2016.
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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.
Ludwig Kappos, MD study director
University Hospital, Basel, Switzerland
17 sites in 17 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 17 sites in 17 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 3 inclusion and 2 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium, Bulgaria, Canada, Croatia, Czechia and 12 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. 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?
Safety assessments (time frame: Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2016.