MedDataX Logo

Trial Outcomes & Findings for Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS) (NCT NCT01382901)

NCT ID: NCT01382901

Last Updated: 2018-02-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Change from Baseline to Day 28

Results posted on

2018-02-20

Participant Flow

Study Period: March 23, 2006 to July 16, 2007 Locations: Hospitals and Medical Clinics (15 total sites)

Participant milestones

Participant milestones
Measure
Ferric Carboxymaltose (FCM) 2 x 500 mg
500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo
Intravenous (IV) solution of placebo on Day 0 and Day 5.
Overall Study
STARTED
24
21
Overall Study
COMPLETED
7
7
Overall Study
NOT COMPLETED
17
14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ferric Carboxymaltose (FCM) 2 x 500 mg
n=24 Participants
500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo
n=21 Participants
Intravenous (IV) solution of placebo on Day 0 and Day 5.
Total
n=45 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
15 Participants
n=7 Participants
35 Participants
n=5 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
Age, Continuous
49.5 years
STANDARD_DEVIATION 11.42 • n=5 Participants
54.1 years
STANDARD_DEVIATION 13.68 • n=7 Participants
51.7 years
STANDARD_DEVIATION 12.59 • n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
11 Participants
n=7 Participants
28 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
10 Participants
n=7 Participants
17 Participants
n=5 Participants
Region of Enrollment
United States
24 participants
n=5 Participants
21 participants
n=7 Participants
45 participants
n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to Day 28

Population: Evaluable Population

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.

Outcome measures

Outcome measures
Measure
Ferric Carboxymaltose (FCM) 2 x 500 mg
n=24 Participants
500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo
n=19 Participants
Intravenous (IV) solution of placebo on Day 0 and Day 5.
International Restless Legs Syndrome (IRLS) Total Score
-8.9 Scores on a scale
Standard Deviation 8.52
-4.0 Scores on a scale
Standard Deviation 0.040

Adverse Events

Ferric Carboxymaltose (FCM) 2 x 500 mg

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ferric Carboxymaltose (FCM) 2 x 500 mg
n=24 participants at risk
500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo
n=21 participants at risk
Intravenous (IV) solution of placebo on Day 0 and Day 5.
Gastrointestinal disorders
Diarrhea
12.5%
3/24 • Number of events 3 • 1 year and 4 months
0.00%
0/21 • 1 year and 4 months
Investigations
Blood phosphorus decreased
12.5%
3/24 • Number of events 3 • 1 year and 4 months
0.00%
0/21 • 1 year and 4 months
Nervous system disorders
Headache
8.3%
2/24 • Number of events 2 • 1 year and 4 months
9.5%
2/21 • Number of events 3 • 1 year and 4 months
Musculoskeletal and connective tissue disorders
Back Pain
4.2%
1/24 • Number of events 1 • 1 year and 4 months
9.5%
2/21 • Number of events 2 • 1 year and 4 months
Psychiatric disorders
Insomnia
0.00%
0/24 • 1 year and 4 months
9.5%
2/21 • Number of events 2 • 1 year and 4 months

Additional Information

Mark Falone, MD

Luitpold Pharmaceuticals, Inc.

Phone: 601-650-4200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60