Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS
were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron
sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The
second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over
four to six hours on two separate dates, separated by two to seven days. The third cohort
received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within
30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.