Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS

Summary

This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation in the study will be for approximately 1 year from Day 0.

Timeline

Start

2015-01

Primary completion

2018-01

Completion

2018-01

Publications

• Earley CJ, Garcia-Borreguero D, Falone M, Winkelman JW. Clinical efficacy and safety of intravenous ferric carboxymaltose for treatment of restless legs syndrome: a multicenter, randomized, placebo-controlled clinical trial. Sleep. 2024 Jul 11;47(7):zsae095. doi: 10.1093/sleep/zsae095.

Drugs

Indications