IV Iron Treatment of Restless Legs Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02484768|
Recruitment Status : Withdrawn (as per GCP sponsor/company decision)
First Posted : June 30, 2015
Last Update Posted : June 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Drug: Iron isomaltoside 1000 Drug: Sodium Chloride 0.9%||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Group A
Infusion of 1000 mg iron isomaltoside 1000 at baseline. The infusion is diluted in 100 mL 0.9 % sodium chloride and given over approximately 15 min
Drug: Iron isomaltoside 1000
Other Name: Monofer
Placebo Comparator: Group B
Infusion of 100 mL 0.9 % sodium chloride at baseline given over approximately 15 min
Drug: Sodium Chloride 0.9%
- To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score [ Time Frame: 6 weeks ]
- Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score [ Time Frame: 3 months ]
- Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS) [ Time Frame: from baseline to t = 12 weeks ]
- Time from baseline to start of RLS medication [ Time Frame: from baseline to t = 6 weeks ]
- Time from baseline to start of RLS medication or non-response (CGI ≥ 3 at week 6) [ Time Frame: from baseline to t = 6 weeks ]
- Type and incidence of adverse drug reactions (ADRs) [ Time Frame: from baseline to t = 18 weeks ]
- Number of adverse events (AEs) of special interest [ Time Frame: from baseline to t = 18 weeks ](i.e. hypersensitivity symptoms such as: urticaria, oedema, bronchospasm, hypotension, cardiorespiratory arrest, syn-cope, unresponsiveness, or loss of consciousness at pre-specified time points in relation to administration of study drug)
- Change in haematology parameters, s-sodium, s-potassium, s-calcium, s-phosphate, s-urea, s-creatinine, s-albumin, s-bilirubin, aspartate aminotransferase (ASAT), and ala-nine aminotransferase (ALAT) from baseline to week 6 and month 3 [ Time Frame: from baseline to t = 18 weeks ]
- Change in vital signs (heart rate and blood pressure) during drug administration [ Time Frame: from baseline to t = 18 weeks ]
- Clinical significant electrocardiogram (ECG) during drug administration [ Time Frame: from baseline to t = 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484768
|Principal Investigator:||Richard Allen, Assoc Prof||Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA|