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

January 22, 2018 updated by: American Regent, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort I
500 mg dose Venofer over 4 hours
Drug: Cohort I
Other Names:
  • 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 Names:
  • 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 Names:
  • iron sucrose injection - Venofer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
Baseline to Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

November 1, 2005

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (ESTIMATE)

May 8, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VEN03032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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