Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.

Key facts

Study ID
NCT01568112
Run by
Biogen
People needed
173
Starts
2012-04-01
Expected to finish
2012-10-01
Last updated by the study team
2016-06-13

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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