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Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis

This study has been completed.
Information provided by:
Millennium Pharmaceuticals, Inc. Identifier:
First received: September 9, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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.

Condition Intervention Phase
Multiple Sclerosis
Drug: MLN1202
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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

Enrollment: 50
Study Start Date: May 2005
Study Completion Date: October 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MLN1202 Drug: MLN1202
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 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:

    1. Cyclophosphamide or mitoxantrone- 6 months prior
    2. Interferons, glatiramer acetate and azathioprine- 12 weeks prior
    3. 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
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Please refer to this study by its identifier: NCT01199640

Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Responsible Party: Clinical Research Monitor, Millennium Pharmaceuticals, Inc. Identifier: NCT01199640     History of Changes
Other Study ID Numbers: MLN120204-063
Study First Received: September 9, 2010
Last Updated: September 9, 2010

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017