Study Details

Open

Pediatric Relapsing Remitting Multiple Sclerosis Study

The purpose of this study is to evaluate a new drug (BIIB017) for the treatment of pediatric patients with Relapsing Remitting Multiple Sclerosis. This drug is already used to treat adults with MS.

Age & Gender

10 years ~ 18 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Orange)

What will be asked of you

There are two parts to this study. Everyone participating will be in Part 1, and you may also choose to be in Part 2. For Part 1, you will have one visit to determine if you are eligible, and 11 clinic visits. You will have an MRI at 4 of the 11 clinic visits. You will also have 2 phone calls. If you choose to participate in part 2, you will visit the clinic 8 times, have one follow-up visit, and you may have another MRI.

Incentives

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

In-person visits:
13-21

Phone or online visits:
2

Total length of participation:
Up to 4 years

Looking for Specific Volunteers

Able to participate:

Have a confirmed diagnosis of relapsing remitting multiple sclerosis
Between 10 and less than 18 years old
At least one MS episode (relapse) in the last 12 months, or at least 2 MS episodes (relapses) in the last 24 months
Able to walk unrestricted or able to walk without aid or rest for at least 100 meters

Not eligible if:

Have been diagnosed with progressive MS
Have had a recent MS relapse within 30 days prior to the study start
Have a history of severe allergic or anaphylactic reactions
Have a history of seizure disorder or unexplained blackouts
Have a history of suicidal thoughts or severe depression within 3 months prior to the study start

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Adult Neurology Outpatient Clinic
UNC Meadowmont
300 Meadowmont Village Cir, Chapel Hill, NC 27517, USA

Additional Study Information

Principal Investigator

Irena Dujmovic Basuroski
Neurology

Study Type

Clinical or Medical
Interventional

Study Topics

Brain, Head, Nervous System
Child and Teen Health
Immune System/Infections

IRB Number

19-0837

ClinicalTrials.gov

NCT03958877