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Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS

NCT02397057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2021-10-12

Study results available
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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.

Conditions

  • Restless Legs Syndrome (RLS)

Interventions

DRUG

Injectafer

OTHER

Placebo

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Falone, MD · American Regent, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397057 on ClinicalTrials.gov