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

Restless Legs Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895232
• Other study ID #: 1VEN03032
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2009
• Last updated: January 22, 2018
• Start date: November 2003
• Est. completion date: November 2005

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Cohort I

• Cohort II

• Cohort III

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	Baseline to Day 84
Secondary	Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)	Quantifies amount of leg movement	Baseline to Day 84