Trial Outcomes & Findings for Intravenous Iron Metabolism in Restless Legs Syndrome (NCT NCT00685815)
NCT ID: NCT00685815
Last Updated: 2025-05-06
Results Overview
Number of weeks that patients were able to remain off treatment for RLS
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 weeks, 4 weeks, and 52 weeks
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
Intravenous Iron (FCM)
Ferric Carboxymaltose (FCM): 500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4
|
Placebo
Placebo
Placebo: 250cc NS IV over one hour, once on Day 3, once on Day 4
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Iron Metabolism in Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=8 Participants
Intravenous Iron (FCM)
Ferric Carboxymaltose (FCM): 500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4
|
Placebo
n=4 Participants
Placebo
Placebo: 250cc NS IV over one hour, once on Day 3, once on Day 4
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 25 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Customized
25 - 50 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Customized
> 50 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks, and 52 weeksPopulation: Intent to treat population
Number of weeks that patients were able to remain off treatment for RLS
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=8 Participants
Intravenous Iron (FCM)
Ferric Carboxymaltose (FCM): 500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4
|
Placebo
n=4 Participants
Placebo
Placebo: 250cc NS IV over one hour, once on Day 3, once on Day 4
|
|---|---|---|
|
Duration Off Treatment
Duration - 2 weeks
|
6 participants
|
3 participants
|
|
Duration Off Treatment
Duration - 20 weeks
|
2 participants
|
0 participants
|
|
Duration Off Treatment
Duration - 52 weeks
|
0 participants
|
1 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place