Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750
mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency
anemia (IDA).
Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior
FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS
symptoms worsen or reoccur.