Phase
Condition
Multiple Sclerosis
Scar Tissue
Memory Loss
Treatment
Natalizumab
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald'scriteria. All other possible neurologic diagnoses must have been reasonably excludedby means of laboratory and/or imaging studies, in the opinion of the investigator.
Must have had an EDSS score between 0.0 and 5.5, inclusive.
Must have had screening MRI or documentation of an MRI within the participant'smedical record within 12 months of the screening visit that revealed 3 or more T2hyperintense lesions consistent with MS.
Was born in Japan, and biological parents and grandparents were of Japanese origin.
Exclusion
Key Exclusion Criteria:
Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)infection within 14 days prior to Screening, between screening and baseline visit,or at baseline visit, including but not limited to a fever (temperature > 37.5degrees Celsius [°C]), new and persistent cough, breathlessness, or loss of tasteand/or smell.
Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positiveindividual.
Diagnosis of primary progressive MS or secondary progressive MS.
An MS exacerbation (relapse) within 30 days prior to enrolment or, in the opinion ofthe investigator, the participant not having stabilized from a previous relapseprior to enrolment (Day 1).
The participant is unable to have a brain MRI scan (e.g., a participant with a metalclip to repair a cerebral aneurysm).
Previous exposure to natalizumab.
Note: Other protocol specified Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Juntendo University Hospital
Bunkyo-ku, 113-8431
JapanSite Not Available
Juntendo University Hospital
Bunkyō City 11790632, 113-8431
JapanSite Not Available
Chiba University Hospital
Chiba 2113015, 260-8677
JapanSite Not Available
Chiba University Hospital
Chiba-shi, 260-8677
JapanSite Not Available
St.Marianna University Hospital
Kawasaki-shi, 216-8511
JapanSite Not Available
National Center of Neurology and Psychiatry
Kodaira-shi, 187-8551
JapanSite Not Available
Kansai Medical University Medical Center
Moriguchi-shi, 570-8507
JapanSite Not Available
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital
Ota-ku, 145-0065
JapanSite Not Available
The Kitasato Institute Kitasato University Hospital
Sagamihara-shi, 252-0375
JapanSite Not Available
National Hospital Organization Hokkaido Medical Center
Sapporo 2128295, 063-0005
JapanSite Not Available
National Hospital Organization Hokkaido Medical Center
Sapporo-shi, 063-0005
JapanSite Not Available
Tohoku Medical and Pharmaceutical University Hospital
Sendai 2111149, 983-8512
JapanSite Not Available
Tohoku Medical and Pharmaceutical University Hospital
Sendai-shi, 983-8512
JapanSite Not Available
Osaka University Hospital
Suita-shi, 565-0871
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba 2110681, 305-8576
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba-shi, 305-8576
JapanSite Not Available
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo-shi, 276-8524
JapanSite Not Available
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital
Ōta-ku 8469289, 145-0065
JapanSite Not Available

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