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

• ClinicalTrials.gov Identifier: NCT00895232
• Recruitment Status: Completed
• First Posted: May 8, 2009
• Results First Posted: June 10, 2015
• Last Update Posted: February 20, 2018
• Sponsor: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT00895232
• Other Study ID Numbers: 1VEN03032
• First Posted: May 8, 2009
• 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; Syndrome; Disease; Pathologic Processes; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Iron; Ferric Oxide, Saccharated; Trace Elements; Micronutrients; Physiological Effects of Drugs; Hematinics