IV Iron Treatment of Restless Legs Syndrome

Summary

The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome. The study is a randomised, comparative, double-blind study with a 3 months extension. Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following treat-ment groups: * Group A (42 subjects): 1000 mg iron isomaltoside 1000 * Group B (21 subjects): Placebo infusion Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg iron isomaltoside 1000 at week 6.

Timeline

Start

2015-01

Primary completion

2015-02

Completion

2015-02

Drugs

Indications