Trial Outcomes & Findings for Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia (NCT NCT02826681)

Last Updated: 2025-04-11

Results Overview

IRLSS (International Restless Legs Syndrome Severity Scale) score change from baseline to Day 42 with comparison between FCM (Ferric Carboxymaltose) vs. Placebo.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Baseline to Day 42

Results posted on

2025-04-11

Participant Flow

Monitored and assessed by phone for RLS symptoms (IRLSS and Hopkins RLS-Sleep Quality Questionnaire \[HRSQ\]) and TEAEs every 9 weeks \~at Weeks 15, 25, 34, 43 and 52. Subjects could have received additional unblinded treatments with FCM if at any time the subject reported worsening of RLS symptoms and laboratory criteria were met. No additional treatment was allowed after Week 46. final clinic visit occurred on Week 52. A clinic visit was not possible, final evaluation was completed by phone.

Participant milestones

Participant milestones
Measure	Injectafer 750 mg undiluted slow IVpush (100 mg/minute) of Injectafer® (Ferric Carboxymaltose - FCM) Injectafer® (Ferric Carboxymaltose - FCM): Intravenous Iron	Normal Saline Placebo (15 ml of Normal Saline \[NS\]) IV push at 2 ml/minute on Day 0 and 7. Placebo (Normal Saline): Normal Saline Solution
Overall Study STARTED	35	35
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	23	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Injectafer n=12 Participants 750 mg undiluted slow IVpush (100 mg/minute) of Injectafer® (Ferric Carboxymaltose - FCM) Injectafer® (Ferric Carboxymaltose - FCM): Intravenous Iron	Normal Saline n=13 Participants Placebo (15 ml of Normal Saline \[NS\]) IV push at 2 ml/minute on Day 0 and 7. Placebo (Normal Saline): Normal Saline Solution	Total n=25 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	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 11.46 • n=5 Participants	44.3 years STANDARD_DEVIATION 10.34 • n=7 Participants	42.3 years STANDARD_DEVIATION 10.87 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 42

Population: Participants who were rated as much or very much improved with the CGI-I on Day 42 with comparison between Injectafer® and Placebo. CGP-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

IRLSS (International Restless Legs Syndrome Severity Scale) score change from baseline to Day 42 with comparison between FCM (Ferric Carboxymaltose) vs. Placebo.

Outcome measures

Outcome measures
Measure	Injectafer n=12 Participants 750 mg undiluted slow IVpush (100 mg/minute) of Injectafer® (Ferric Carboxymaltose - FCM) Injectafer® (Ferric Carboxymaltose - FCM): Intravenous Iron	Normal Saline n=12 Participants Placebo (15 ml of Normal Saline \[NS\]) IV push at 2 ml/minute on Day 0 and 7. Placebo (Normal Saline): Normal Saline Solution
Treatment Phase I: IRLSS Score Change	12 Participants	12 Participants

Adverse Events

Injectafer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Falone

American Regent, Inc.

Phone: 631.772.3544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place