MedTrace Logo

Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)

NCT02739542 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-05-11

Study results available
· View outcomes & findings →

Summary

The purpose of this investigation is to systematically study the efficacy of Tecfidera in those individuals who possess incidental white matter anomalies within the brain following a MRI study that is performed for a reason other than for the evaluation of MS (multiple sclerosis).

Conditions

  • Multiple Sclerosis (MS)

Interventions

DRUG

Tecfidera

Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.

DRUG

Placebo

Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Darin T Okuda, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-19
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739542 on ClinicalTrials.gov