NCT02484768

IV Iron Treatment of Restless Legs Syndrome

A Phase II, Six-week, Randomised, Comparative, Double-blind Study of Intravenous Iron Isomaltoside 1000 Versus Placebo in Subjects With Restless Leg Syndrome With a 3 Month Extension

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

RLS is a disorder of sensation with a prevalence of around 2-5 % of the population. RLS is extremely responsive to dopaminergic agents, but a second issue is that iron deficiency states may precipitate RLS in as much as 25-30 % of subjects with iron deficiency. RLS appears to be related to deficits in brain iron content and metabolism. Magnetic resonance imaging (MRI) images demonstrate a decrease in substantia nigra and red nucleus iron content. The severity of this decrease in brain iron content is correlated with the severity of symptoms. A number of patients are quite resistant to dietary iron repletion but do resolve symptoms with high doses of intravenous (IV) iron. For the individual subject, there will be 4 phases to the study which includes teleconferences (TCs) and 2 visits. The treatment and treatment evaluation is the main study.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Iron isomaltoside 1000	Intravenous treatment
DRUG	Sodium Chloride 0.9%	Intravenous treatment

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2015-06-30
• Last updated: 2015-06-30