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IV Iron Treatment of Restless Legs Syndrome

NCT02484768 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-06-30

No results posted yet for this study

Summary

The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome.

The study is a randomised, comparative, double-blind study with a 3 months extension. Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following treat-ment groups:

* Group A (42 subjects): 1000 mg iron isomaltoside 1000
* Group B (21 subjects): Placebo infusion

Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg iron isomaltoside 1000 at week 6.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Iron isomaltoside 1000

Intravenous treatment

DRUG

Sodium Chloride 0.9%

Intravenous treatment

Sponsors & Collaborators

  • BioStata

    collaborator INDUSTRY

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Richard Allen, Assoc Prof · Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

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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 NCT02484768 on ClinicalTrials.gov