NCT02428231

Tecfidera Slow-Titration Study

A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	Participants will be dosed twice daily for 12 weeks.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-04-28
• Last updated: 2017-05-05
• Results posted: 2017-05-05

Locations

20 sites across 4 countries: United States, Belgium, Czechia, Italy