At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 209 enrolled
Drug / intervention
Injectafer +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blinded, Multi-Center, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Restless Legs Syndrome (RLS)
In Brief
A Phase 3 clinical trial evaluating Injectafer and Placebo for Restless Legs Syndrome (RLS). Completed, enrolled 209 participants across 19 sites.
Detailed Summary
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation in the study will be for approximately 1 year from Day 0.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome (RLS)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedMar 2015
Primary CompletionJan 2018
TodayJul 2026
First PostedMar 24, 2015
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 11.3 years ago
Interventions
Injectaferdrug
Placeboother