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NCT02397057 · ClinicalTrials.gov registry record · Phase 3
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
A Phase 3 study, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 209
- Enrollment target
NCT02397057: Completed Phase 3 study, sponsored by American Regent.
NCT02397057 is a Phase 3 study that has completed, run by American Regent. The registered enrollment target is 209 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397057, a Phase 3 study, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 209 participants
- Enrollment target
Study 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.
Primary Outcome
Summary of the actual values of IRLS total score on baseline and Day 42, and the change from baseline to Day 42. Eligible subjects were to have met the following requirements prior to receiving additional treatment: A baseline score ≥ 15 on the International Restless Legs Syndrome (IRLS) Rating Scale. The minimum score is 15 with the maximum of 40. A score of less than 15 is not an indicator of RLS. However, a score of 15 or greater is an indicator of RLS. Further increase indicates more sever
Interventions
- OTHER Placebo
- DRUG Injectafer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-01 |
| Phase | Phase 3 |
What the finished NCT02397057 record still lists
NCT02397057 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02397057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02397057 about?
NCT02397057 is a clinical study titled "Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS". 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...
What is the current status of trial NCT02397057?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 209 participants. The study started on 2015-01. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02397057?
The interventions under investigation include: Placebo (OTHER), Injectafer (DRUG).
Who is sponsoring clinical trial NCT02397057?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02397057's enrollment target sits among peer trials
209 1345th of 2000 higher than 656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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