Back to results

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

Primary Purpose

Restless Legs Syndrome

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cohort I

Cohort II

Cohort III

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort I

Cohort II

Cohort III

Arm Description

500 mg dose Venofer over 4 hours

500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7

500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours

Outcomes

Primary Outcome Measures

Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale

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)

Quantifies amount of leg movement

Full Information

NCT ID

NCT00895232

First Posted

May 7, 2009

Last Updated

January 22, 2018

Sponsor

American Regent, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00895232

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American Regent, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort I

Arm Type

Experimental

Arm Description

500 mg dose Venofer over 4 hours

Arm Title

Cohort II

Arm Type

Experimental

Arm Description

500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7

Arm Title

Cohort III

Arm Type

Experimental

Arm Description

500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours

Intervention Type

Drug

Intervention Name(s)

Cohort I

Other Intervention Name(s)

iron sucrose injection - Venofer

Intervention Type

Drug

Intervention Name(s)

Cohort II

Other Intervention Name(s)

iron sucrose injection - Venofer

Intervention Type

Drug

Intervention Name(s)

Cohort III

Other Intervention Name(s)

iron sucrose injection - Venofer

Primary Outcome Measure Information:

Title

Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale

Description

Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])

Time Frame

Baseline to Day 84

Secondary Outcome Measure Information:

Title

Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)

Description

Quantifies amount of leg movement

Time Frame

Baseline to Day 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs