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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199640

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

No publications provided

Responsible Party: Clinical Research Monitor, Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01199640     History of Changes
Other Study ID Numbers: MLN120204-063
Study First Received: September 9, 2010
Last Updated: September 9, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014