Conditions: Restless Legs Syndrome
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 500 mg dose Venofer over 4 hours arm 2: 500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 arm 3: 500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours

Interventions: intervention 1: Cohort I intervention 2: Cohort II intervention 3: Cohort III
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: