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

This study has been completed.

Sponsor:

Information provided by:

Luitpold Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01382901

First received: February 23, 2011

Last updated: July 8, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 23, 2011
Last Updated Date	July 8, 2011
Start Date ^ICMJE	March 2006
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 31, 2011)	International Restless Legs Syndrome (IRLS) Total Score [ Time Frame: Change from Baseline to Day 28 ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01382901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: May 31, 2011)	Safety Evaluations for All Reported Participants to Include: Adverse Events and Serious Adverse Events [ Time Frame: Day of initial treatment with study drug through completion of Treatment Phase of the study (Day 56) or 28 days after last treatment, whichever was later. ] [ Designated as safety issue: Yes ] All safety analyses were performed using the Safety Population, defined as all subjects who received at least 1 dose of study drug.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
Official Title ^ICMJE	A Phase 2a Study Evaluating the Efficacy and Safety of a Novel Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
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)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Restless Legs Syndrome (RLS)
Intervention ^ICMJE	Drug: Ferric Carboxymaltose (FCM) Other Name: VIT-45 Drug: Placebo
Study Arm (s)	Experimental: Intravenous (IV) Iron Intervention: Drug: Ferric Carboxymaltose (FCM) Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	July 2007
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnant or lactating women. Severe peripheral vascular disease with significant skin changes. Seizure disorder currently being treated with medication. Baseline ferritin > 300 ng/mL. Baseline TSAT > or = to 45%. History of hemochromatosis or hemosiderosis or other iron storage disorders. AST or ALT greater than the upper limit of normal. Hemoglobin greater than the upper limit of normal. Calcium or phosphorous outside the normal range. Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis. Known positive HIV-1/HIV-2 antibodies (anti-HIV). Received an investigational drug within 30 days before randomization. Chronic alcohol or drug abuse within the past 6 months. Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) III or IV, or poorly controlled hypertension according to the judgment of the investigator. Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk. Subject unable to comply with study requirements.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01382901
Other Study ID Numbers ^ICMJE	1VIT05009
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Luitpold Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Luitpold Pharmaceuticals
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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