A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable

Millennium Pharmaceuticals, Inc.0 sites160 target enrollmentFebruary 4, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 160
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

February 4, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Each patient must meet all of the following inclusion criteria to be enrolled in the pre\-treatment phase of the study:
•Be 18 years of age or older
•Have a diagnosis of RRMS
•Have had at least 1 documented relapse of MS within 18 months prior to study entry
•Have an Expanded Disability Status Score (EDSS) of 0 to 5\.5, inclusive (see Study Manual for calculation details)
•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 nor breast\-feeding. Confirmation that the patient is not pregnant must be established by a negative serum hCG pregnancy test within 7 days of study entry and again within 7 days prior to the first administration of study drug.
•Have given written informed consent prior to any study\-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
•Each patient must meet the following inclusion criteria to be enrolled in the treatment phase of the study:

•Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
•Have a diagnosis of PPMS or SPMS
•Have received any investigational drug or experimental procedure within 3 months prior to Study Day 0
•If the patient has received disease\-modifying cyclophosphamide (Cytoxan®) or mitoxantrone \[Novantrone®] for MS, that treatment must have discontinued 6 months prior to study Day 0\.
•If the patient has received the following prior disease modifying treatments: (interferons \[Avonex®, Rebif®, Betaseron®/Betaferem®], glatiramer acetate \[Copaxone®], azathioprine \[Imuran®]) for MS, that treatment must have discontinued at least 12 weeks prior to study Day 0\.
•If the patient has received disease\-modifying methotrexate, IV immunoglobulin, cyclosporin, or plasma exchange for MS, that treatment must have discontinued at least 8 weeks prior to study Day 0\.
•If the patient has received prior treatment with corticosteroids for MS, the patient must have discontinued that treatment at least 8 weeks prior to Study Day 0\.
•If the patient has ever been exposed to Tysabri® (natalizumab) or any other VLA\-4 (a4b1\) antagonist.
•Have an active infection or be considered to be at high risk for developing an infection, including reactivation of latent tuberculosis, in the opinion of the investigator.
•Have a history of hepatitis B, C, or human immunodeficiency virus (HIV)