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

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01199640
First received: September 9, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 9, 2010
September 9, 2010
May 2005
July 2007   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
No Changes Posted
Not Provided
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Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
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).
Experimental: MLN1202
Intervention: Drug: MLN1202
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01199640
MLN120204-063
No
Clinical Research Monitor, Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP