Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments

This study has been completed.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals Identifier:
First received: May 7, 2009
Last updated: June 8, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Restless Legs Syndrome
Drug: Cohort I
Drug: Cohort II
Drug: Cohort III
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale [ Time Frame: Baseline to Day 84 ] [ Designated as safety issue: No ]
    Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])

Secondary Outcome Measures:
  • Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's) [ Time Frame: Baseline to Day 84 ] [ Designated as safety issue: No ]
    Quantifies amount of leg movement

Enrollment: 21
Study Start Date: November 2003
Study Completion Date: November 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort I
500 mg dose Venofer over 4 hours
Drug: Cohort I
Other Name: iron sucrose injection - Venofer
Experimental: Cohort II
500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7
Drug: Cohort II
Other Name: iron sucrose injection - Venofer
Experimental: Cohort III
500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours
Drug: Cohort III
Other Name: iron sucrose injection - Venofer


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed consent.
  • Male or female subjects > 18 yrs. old.
  • RLS signs and symptoms affirming diagnosis.
  • A baseline score > or = to 15 is required on the International RLS Study Group Rating Scale (IRLSSG).
  • At least one leg with an average baseline Periodic Leg Movement (PLM) while asleep > or = to 15 movements per hour by actigraphy.
  • Subjects on dopa-adrenergic therapy or other RLS treatments must be off therapy at least one week before any baseline RLS assessments and actigraphy measurement are obtained.
  • Subject has regular sleep hours between 9 p.m. and 9 a.m.
  • Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control.

Exclusion Criteria:

  • Known intolerance to Venofer.
  • RLS which is ascribed to renal disease.
  • RLS 2° to other CNS disease or injury.
  • Any pain related or sleep related disorders which may confound the outcome measures.
  • History of neuroleptic akinesia.
  • Concurrent use of oral iron supplement.
  • Parenteral iron use within the past 6 months.
  • Active infection.
  • Currently being treated for asthma.
  • Severe peripheral vascular disease with significant skin changes.
  • Seizure disorder currently being treated with medication.
  • Serum ferritin level > 300 ng/mL or a TSAT > or = to 45% at baseline or a history of hemochromatosis.
  • Significant cardiovascular or hepatic disease or any other pre-existing medical condition or disease which in the view of the investigator participation in this study would put the subject's disease management at risk or the subject would be unable to comply with the study requirements.
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No publications provided

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00895232     History of Changes
Other Study ID Numbers: 1VEN03032
Study First Received: May 7, 2009
Results First Received: June 29, 2009
Last Updated: June 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic
Ferric Compounds
Ferric oxide, saccharated
Growth Substances
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements processed this record on November 30, 2015