Overview

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

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
American Regent, Inc.
Luitpold Pharmaceuticals
Treatments:
Ferric Compounds