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

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ClinicalTrials.gov Identifier: NCT01382901
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : June 27, 2011
Last Update Posted : February 20, 2018
Sponsor:
Information provided by:
Luitpold Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Restless Legs Syndrome (RLS)
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Placebo
Enrollment 45
Recruitment Details Study Period: March 23, 2006 to July 16, 2007 Locations: Hospitals and Medical Clinics (15 total sites)
Pre-assignment Details  
Arm/Group Title Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo
Hide Arm/Group Description 500mg intravenous (IV) dose of FCM on Day 0 and Day 5. Intravenous (IV) solution of placebo on Day 0 and Day 5.
Period Title: Overall Study
Started 24 21
Completed 7 7
Not Completed 17 14
Arm/Group Title Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo Total
Hide Arm/Group Description 500mg intravenous (IV) dose of FCM on Day 0 and Day 5. Intravenous (IV) solution of placebo on Day 0 and Day 5. Total of all reporting groups
Overall Number of Baseline Participants 24 21 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  83.3%
15
  71.4%
35
  77.8%
>=65 years
4
  16.7%
6
  28.6%
10
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 21 participants 45 participants
49.5  (11.42) 54.1  (13.68) 51.7  (12.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
Female
17
  70.8%
11
  52.4%
28
  62.2%
Male
7
  29.2%
10
  47.6%
17
  37.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 21 participants 45 participants
24 21 45
1.Primary Outcome
Title International Restless Legs Syndrome (IRLS) Total Score
Hide Description 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.
Time Frame Change from Baseline to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo
Hide Arm/Group Description:
500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Intravenous (IV) solution of placebo on Day 0 and Day 5.
Overall Number of Participants Analyzed 24 19
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-8.9  (8.52) -4.0  (0.040)
Time Frame 1 year and 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo
Hide Arm/Group Description 500mg intravenous (IV) dose of FCM on Day 0 and Day 5. Intravenous (IV) solution of placebo on Day 0 and Day 5.
All-Cause Mortality
Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferric Carboxymaltose (FCM) 2 x 500 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/24 (37.50%)      6/21 (28.57%)    
Gastrointestinal disorders     
Diarrhea  3/24 (12.50%)  3 0/21 (0.00%)  0
Investigations     
Blood phosphorus decreased  3/24 (12.50%)  3 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1/24 (4.17%)  1 2/21 (9.52%)  2
Nervous system disorders     
Headache  2/24 (8.33%)  2 2/21 (9.52%)  3
Psychiatric disorders     
Insomnia  0/24 (0.00%)  0 2/21 (9.52%)  2
1
Term from vocabulary, undefined
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark Falone, MD
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 601-650-4200
ClinicalTrials.gov Identifier: NCT01382901     History of Changes
Other Study ID Numbers: 1VIT05009
First Submitted: February 23, 2011
First Posted: June 27, 2011
Results First Submitted: February 23, 2011
Results First Posted: June 27, 2011
Last Update Posted: February 20, 2018