Status:
COMPLETED
Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01199640
Start Date
May 1 2005
End Date
October 1 2007
Last Update
September 13 2010
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