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Relapsing Remitting Multiple Sclerosis Study for Pediatric Persons aged 10-17 years old

University of North Carolina at Chapel Hill


Description

The purpose of this study is to evaluate a new drug (BIIB017) for the treatment of pediatric subjects with Relapsing Remitting Multiple Sclerosis.


Keywords:

Brain/Head, Neurological Disorders, Pediatrics


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
10 - 17 years


Gender
Any


Study Population

Male and female subjects, aged from 10 to less than 18 years, with a confirmed diagnosis of relapsing remitting multiple sclerosis.


Investigator

Irena Dujmovic Basuroski
Clinical Associate Professor
Neurology

For questions, contact:

Patricia Orozco
orozcop@neurology.unc.edu
(919) 966-5039


Recruitment Period End

May 19, 2023

Location

Primary Location
UNC Hospitals Neurology Clinic

Secondary Location
UNC Hospitals Imaging and Spine Center

Study Qualifications

Gender Any

Age Range 10 - 17 years

Participant qualification(s) Parents must be able and willing to sign informed consent and authorization and subjects should provide assent if necessary. Subjects should be 10 to less than 18 years of age. Subjects must have a confirmed diagnosis of relapsing remitting multiple sclerosis.

Not eligible if: Subjects will be excluded if: they have been diagnosed with primary progressive, secondary progressive, or progressive relapsing MS; have any disorders that mimic multiple sclerosis; history of severe allergic or anaphylactic reactions; known allergy to any component of Avonex or BIIB017; recent history of seizure disorder or unexplained blackouts; recent history of suicidal ideation or an episode of severe depression; recent MS relapse; other major disease, as determined by the investigator that would prevent participation in the study; abnormal blood screen (specific limits can be explained if necessary); history of malignant disease such as tumors; positive test result of HIV; positive test result of Hepatitis C. Anything that would place the subject at increased risk or that makes the subject unsuitable for enrollment.

Number of Visits

    » 13 In person visit(s)

    Part 1 (required): 1 Screening, 11 clinic (you will have an MRI at 4 of these), and 1 Follow up. Part 2 (optional): 8 clinic (MRIs may be done if the doctor thinks it's needed)

    » 2 Remote visit(s)

    2 Phone

Participation Period

Part 1 only: 104 weeks (just over 2 years). Part 1 + Part 2: 196 weeks (just over 4 years)

Compensation

Reimbursement will be provided for travel, meals, and lodging expenses, if needed

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.