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BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

NCT02430532 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-04-26

Study results available
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Summary

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

Conditions

  • Multiple Sclerosis, Secondary Progressive

Interventions

DRUG

dimethyl fumarate

capsule

OTHER

Placebo

matched placebo capsule

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Belgium
  • Czechia
  • Netherlands
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

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 NCT02430532 on ClinicalTrials.gov