Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
Public ClinicalTrials.gov record NCT02397057. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02397057
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 209 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2015 (Actual)
- Primary completion
- Jan 2018 (Actual)
- Completion
- Jan 2018 (Actual)
- Last update posted
- Oct 12, 2021
2015 – 2018
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Synergy San Diego | National City | California | 91950 | — |
| Desert Valley Research | Rancho Mirage | California | 92270 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| Neurology Offices of South FL | Boca Raton | Florida | 33428 | — |
| Elite Research Institute | Miami | Florida | 33169 | — |
| MidAmmerica Neuroscience Institute | Lenexa | Kansas | 66214-1505 | — |
| Central Kentucky Research Assoc., Inc. | Lexington | Kentucky | 40509 | — |
| Neuromedical Clinical of Central Louisiana | Alexandria | Louisiana | 71301 | — |
| Ctr for Brain & Neuro Care, LLC | Fulton | Maryland | 20759 | — |
| Massachusetts General Hospital, Sleep Disorders Clinical Research Program | Boston | Massachusetts | 02114 | — |
| Desert Neurology | Las Vegas | Nevada | 89119 | — |
| Neurology Center of Las Vegas | Las Vegas | Nevada | 89128 | — |
| Guilford Neurologic Associates | Greensboro | North Carolina | 27405 | — |
| Metrolina Neurological Associates | Old Point Station | South Carolina | 29707 | — |
| Saad Upstate Neurology | Spartanburg | South Carolina | 29307 | — |
| Tri-State Mountain Neurology Associates | Johnson City | Tennessee | 37604 | — |
| Egret Bay Neurology | Houston | Texas | 77058 | — |
| The Polyclinic, Madison Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02397057, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 12, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02397057 live on ClinicalTrials.gov.