Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis — ASSURE  

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title: A Phase 4, Randomized, Double-Blind Study With a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects With Relapsing-Remitting Multiple Sclerosis Treated With Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules

Status Completed

Clinical Trial Summary

The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetyl salicylic acid [ASA]) taken twice a day (BID) with DMF (dimethyl fumarate) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting.

Secondary objectives of this study are: To evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; To evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.

Clinical Trial Description

There are two parts to this study: Double-Blind Period from randomization through Week 12; Safety Extension Period from Week 13 to Week 48 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flushing
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

• NCT number: NCT02090413
• Study type: Interventional
• Source: Biogen
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Completion date: November 2015