Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

NCT01382901 | Completed Phase 2 Results

• 1 other identifier: 1VIT05009
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)

Conditions

Restless Legs Syndrome (RLS)

Outcome Measures

Primary Outcomes (1)

• International Restless Legs Syndrome (IRLS) Total Score

  The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.

  Change from Baseline to Day 28

Study Arms (2)

Intravenous (IV) Iron

EXPERIMENTAL

Drug: Ferric Carboxymaltose (FCM)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ferric Carboxymaltose (FCM) DRUG

Also known as: VIT-45

Intravenous (IV) Iron

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects \> or = to 18 years old, and able to give informed consent to the study.
• RLS signs and symptoms affirming diagnosis. The IRLS Diagnostic Criteria for RLS must be met.
• Subjects have RLS symptoms \> or = to 5 nights per week for at least the past 3 months.
• A baseline score \> or = to 15 on the IRLS Rating Scale.
• At least one leg with an average baseline Periodic Leg Movement while asleep (PLMS) \> or = to 15 movements per hour and at least 3 days of baseline PLMS data is measurable in each leg.
• Subjects on anti-depressants, sleep medications, dopamine agonists, benzodiazepines, narcotics or other RLS treatments must be off therapy at least one week or 5 half lives, whichever is longer before any baseline RLS assessments and PLM measurements 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:

• RLS 2° to other CNS disease or injury. Such disorders include peripheral neuropathy, neurodegenerative disorders, and multiple sclerosis.
• RLS 2° to Chronic Kidney Disease.
• Any pain related or sleep related disorders (e.g. sleep apnea) which may confound the outcome measures.
• History of neuroleptic akathisia.
• Oral iron use (including multivitamins with iron) after screening.
• Parenteral iron use within 4 weeks prior to screening.
• Parenteral iron use \> 125 mg per week within 4 to 8 weeks prior to screening.
• History of \> or = to 10 blood transfusions in the past 2 years.
• Anticipated need for blood transfusion during the study.
• Known hypersensitivity reaction to any component to FCM.
• Previously participated in an FCM clinical trial.
• Chronic or serious active severe infection.
• Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for \> 5 years).
• Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
• Receiving prescription medication for the treatment of bronchospasm.

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

mfalone@luitpold.com

601-650-4200

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: June 27, 2011
• Study Start: March 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: February 20, 2018
• Results First Posted: June 27, 2011

Record last verified: 2018-01