Multiple SclerosisPhase 2NCT01199640
Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
A Phase 2 study testing MLN1202 in people with Multiple Sclerosis, run by Millennium Pharmaceuticals, Inc..
Trial summary
This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose cohorts enrolling a total of 50 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MLN1202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Oct 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient was to have met all of the following inclusion criteria to be enrolled in the study:
- 18 years of age or older
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- An Expanded Disability Status Score (EDCC) of 0 to 5.5, inclusive
- Be willing and able to comply with the protocol for the duration of the study period
- Be willing to use adequate "double-barrier" contraceptive methods for the duration of the study period
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- If female, must be neither pregnant or breast-feeding
- Written informed consent
- To be enrolled in the treatment phase of the study each patient must have a total of at least 2 new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions seen over the series of 3 pretreatment magnetic resonance imaging (MRI)s.
Who cannot join
- Patients meeting any of the following exclusion criteria were not to be enrolled in the study:
- Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS)
- Received any investigational drug or experimental procedure within 3 months prior to study day 0
- If the patient has received disease-modifying treatments they must be discontinued prior to study day 0 as follows:
- Cyclophosphamide or mitoxantrone- 6 months prior
- Interferons, glatiramer acetate and azathioprine- 12 weeks prior
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- Methotrexate, IV immunoglobulin, cyclosporin, plasma exchange or corticosteroids- 8 weeks prior
- Never have been exposed to Tysabri® (natalizumab)or any other VLA-4 (α4β1)antagonist
- Have an active infection or be considered to be at high risk for developing an infection
- Have a history of hepatitis B, C or human immunodeficiency virus (HIV)
- Have a chest X-ray within 6 months of study day 0 with clinically significant findings or abnormalities
- Have inadequate renal or hepatic function
- Have a known history of cancer, except for distant history (>10 years) of carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
- Received any live, attenuated vaccinations within 30 days prior to study day 0
- Have a history of illicit drug or alcohol abuse within 5 years of study day 0
- Have a history of hypersensitivity to prior monoclonal antibody (mAb) treatment
- Have a history of allergy or sensitivity to Gd
- Have a history that would preclude serial MRI scans
About this study
Official title: A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.
- Conditions
- Multiple Sclerosis
- Being tested
- MLN1202
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN1202Drug
Patients received 5 intravenous (IV) infusions of the study drug. The first 3 infusions were administered at 15-day intervals, followed by 2 infusions at 30-day intervals. Patients were randomized to receive 1 of 2 doses of MLN1202 (4mg/kg or 8mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| MLN1202 | Experimental | Not described Receives: Drug: MLN1202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS)
Vital sign measurement, physical examinations, multiple sclerosis (MS) relapses, changes in expanded disability status scale (EDSS) scores and standard laboratory test results, as well as the incidence of adverse events and serious adverse events
Measured: Day 61- Day 330
To determine the efficacy of MLN1202 in patients with RRMS
Comparing the mean number of new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions on magnetic resonance imaging (MRI) scans during the pretreatment phase with the mean number of new Gd-enhancing lesions found during the treatment phase
Measured: Day 0- Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startMay 2005
- Primary completionJul 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199640
- Sponsor's protocol ID
- MLN120204-063
- Status last verified
- Sep 2010
- First submitted
- 9 Sep 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01199640
- Acronym / sponsor ID
- MLN120204-063
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 13 Sep 2010 (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.
This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MLN1202 | Experimental | Drug: MLN1202 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Each patient was to have met all of the following inclusion criteria to be enrolled in the study:
- 18 years of age or older
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- An Expanded Disability Status Score (EDCC) of 0 to 5.5, inclusive
- Be willing and able to comply with the protocol for the duration of the study period
Key exclusion criteria (18 listed)
- Patients meeting any of the following exclusion criteria were not to be enrolled in the study:
- Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS)
- Received any investigational drug or experimental procedure within 3 months prior to study day 0
- If the patient has received disease-modifying treatments they must be discontinued prior to study day 0 as follows:
- Never have been exposed to Tysabri® (natalizumab)or any other VLA-4 (α4β1)antagonist
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 |
|---|---|---|
| MLN1202Patients received 5 intravenous (IV) infusions of the study drug. The first 3 infusions were administered at 15-day intervals, followed by 2 infusions at 30-day intervals. Patients were randomized to receive 1 of 2 doses of MLN1202 (4mg/kg or 8mg/kg). | Drug | MLN1202 |
Primary outcome
To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS)
Time frame: Day 61- Day 330
Vital sign measurement, physical examinations, multiple sclerosis (MS) relapses, changes in expanded disability status scale (EDSS) scores and standard laboratory test results, as well as the incidence of adverse events and serious adverse events
To determine the efficacy of MLN1202 in patients with RRMS
Time frame: Day 0- Day 180
Comparing the mean number of new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions on magnetic resonance imaging (MRI) scans during the pretreatment phase with the mean number of new Gd-enhancing lesions found during the treatment phase
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 13 Sep 2010.
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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.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLN1202 in people with Multiple Sclerosis, run by Millennium Pharmaceuticals, Inc..
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 18 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 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS) (time frame: Day 61- Day 330). The study lists 2 primary outcomes in all. 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 13 Sep 2010.