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.