drugset / Trial / NCT02428231

Tecfidera Slow-Titration Study

NCT02428231

Phase 3 Terminated 62 enrolled Biogen
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.

Timeline

Start
2015-04
Primary completion
2015-12
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject dimethyl fumarate Unknown 240 mg

Indications