Multiple Sclerosis
Conditions
Brief 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. Efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.
Interventions
DRUGMLN1202
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).
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * 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.
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS) | 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 | 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 |
Outcome results
None listed