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

NCT00895232 | Completed Phase 2 Results

• 1 other identifier: 1VEN03032
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline to Day 84

Study Arms (3)

Cohort I

EXPERIMENTAL

500 mg dose Venofer over 4 hours

Drug: Cohort I

Cohort II

EXPERIMENTAL

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

Drug: Cohort II

Cohort III

EXPERIMENTAL

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

Drug: Cohort III

Interventions

Cohort I DRUG

Also known as: iron sucrose injection - Venofer

Cohort I

Cohort II DRUG

Also known as: iron sucrose injection - Venofer

Cohort II

Cohort III DRUG

Also known as: iron sucrose injection - Venofer

Cohort III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: November 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: November 1, 2005
• Last Updated: November 7, 2024
• Results First Posted: June 10, 2015

Record last verified: 2024-11