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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

NCT00027300•Biogen

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
•Between the ages of 18 and 50, inclusive.
•Baseline EDSS score between 0.0 and 5.0, inclusive.
•Have experienced at least one relapse within the 12 months prior to randomization.
•Cranial MRI scan demonstrating lesion(s) consistent with MS.
•Have given written informed consent to participate in the study.

Exclusion Criteria

•Primary progressive, secondary progressive, or progressive relapsing MS.
•MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
•A clinically significant infectious illness within 30 days prior to randomization.
•History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
•History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
•Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.
•Abnormal blood tests performed at the Screening Visit.

Locations (53)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

East Bay Region Associates in Neurology

Berkeley, California, United States

UC Davis School of Medicine, Department of Neurology

Davis, California, United States

Yale University School of Medicine, Department of Neurology

New Haven, Connecticut, United States

University of Miami School of Medicine, Department of Neurology

Miami, Florida, United States

University of Kansas Medical Center, Department of Neurology

Kansas City, Kansas, United States

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Gimbel MS Center

Teaneck, New Jersey, United States

CMRRC

Albuquerque, New Mexico, United States

Key Dates

Start Date

November 1, 2001

Primary Completion Date

November 1, 2004

Completion Date

January 1, 2005

Last Updated

January 9, 2017

Enrollment

900

ACTUAL participants

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

DRUG

Placebo

DRUG

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

NCT05359653

Multiple Sclerosis (MS)Multiple Sclerosis, Relapsing-Remitting+5 more

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RECRUITINGNA

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

NCT06390930

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

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