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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895232
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : June 10, 2015
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Cohort I Drug: Cohort II Drug: Cohort III Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Restless Legs
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale [ Time Frame: Baseline to Day 84 ]
    Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])

Secondary Outcome Measures :
  1. Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's) [ Time Frame: Baseline to Day 84 ]
    Quantifies amount of leg movement

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00895232     History of Changes
Other Study ID Numbers: 1VEN03032
First Posted: May 8, 2009    Key Record Dates
Results First Posted: June 10, 2015
Last Update Posted: February 20, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs