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Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

06:35 EDT 18th April 2014 | BioPortfolio

Summary

This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Restless Legs Syndrome

Intervention

Pregabalin (Lyrica), Placebo

Location

University of South Florida
Tampa
Florida
United States
33612

Status

Withdrawn

Source

University of South Florida

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

A disorder characterized by aching or burning sensations in the lower and rarely the upper extremities that occur prior to sleep or may awaken the patient from sleep. Complying with an irresistible urge to move the affected limbs brings temporary relief. Sleep may become disrupted, resulting in excessive daytime hypersomnolence. This condition may be associated with UREMIA; DIABETES MELLITUS; and rheumatoid arthritis. Restless Legs Syndrome differs from NOCTURNAL MYOCLONUS SYNDROME in that in the latter condition the individual does not report adverse sensory stimuli and it is primarily a sleep-associated movement disorder. (Adams et al., Principles of Neurology, 6th ed, p387; Schweiz Rundsch Med Prax 1997 Apr 30;86(18):732-736)

A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Purplish or brownish red discoloration of the skin associated with increase in circulating polyclonal globulins, usually GAMMA-GLOBULINS. This syndrome often occurs on the legs of women aged 20 to 40 years.

A condition caused by one or more episodes of DEEP VEIN THROMBOSIS, usually the blood clots are lodged in the legs. Clinical features include EDEMA; PAIN; aching; heaviness; and MUSCLE CRAMP in the leg. When severe leg swelling leads to skin breakdown, it is called venous STASIS ULCER.

Clinical Trials [740 Associated Clinical Trials listed on BioPortfolio]

Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Neuroma Injections to Treat Restless Legs Syndrome - RCT

The purpose of this study is to determine whether, in a randomized, placebo-controlled trial, restless legs syndrome (RLS) can be caused by pinched and damaged foot nerves called neuromas.

XP13512 Versus Placebo in Patients With Restless Legs Syndrome

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Intravenous Iron Metabolism in Restless Legs Syndrome

To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.

PubMed Articles [4772 Associated PubMed Articles listed on BioPortfolio]

Restless legs syndrome and its associated risk factors in Parkinson's disease.

Introduction. Restless legs syndrome has been shown to negatively impact the quality of life of patients. Studies have shown an association between restless legs syndrome and Parkinson's disease. We a...

Demographic and clinical characteristics of patients with restless legs syndrome in spine clinic.

The restless legs syndrome (RLS) is a common disorder affecting up to 5% to 15% of the general population, in which the incidence increases with age, and includes paresthesia in the legs. The purpose...

Nocturnal eating is part of the clinical spectrum of restless legs syndrome and an underestimated risk factor for increased body mass index.

We aimed to investigate the prevalence of night eating syndrome (NES) in a large cohort of patients with restless legs syndrome (RLS).

Restless legs syndrome: an early clinical feature of Parkinson disease in men.

The association between restless legs syndrome (RLS) and Parkinson disease has been extensively studied, but the temporal relationship between the two remains unclear. We thus conduct the first prospe...

The Prevalence of Migraine in Restless Legs Syndrome.

While previous studies have investigated the prevalence of restless legs syndrome (RLS) in patients with migraine, we aimed to explore the prevalence and characteristics of migraine in adult patients...

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