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Restless Legs Syndrome (RLS) clinical trials

View clinical trials related to Restless Legs Syndrome (RLS).

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NCT ID: NCT03053427 Completed - Clinical trials for Restless Legs Syndrome (RLS)

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Start date: March 30, 2017
Phase: Phase 4
Study type: Interventional

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.

NCT ID: NCT02397057 Completed - Clinical trials for Restless Legs Syndrome (RLS)

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

Start date: January 2015
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01981941 Completed - Clinical trials for Restless Legs Syndrome (RLS)

Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

Start date: November 5, 2013
Phase: Phase 4
Study type: Interventional

To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.

NCT ID: NCT01823770 Completed - Clinical trials for Restless Legs Syndrome (RLS)

Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome

Start date: November 26, 2012
Phase: Phase 4
Study type: Interventional

Several studies report association between restless legs syndrome (RLS), HTA and cardiovascular diseases . The mechanisms involved in this relationship remained unknown, but several evidences favor the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS. Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could contribute to the risk of high blood pressure, heart disease, and stroke in patients with RLS, especially in the elderly. Several studies already reported that dopaminergic agonists reduce the severity of RLS and the PLMS index. Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic dysfunctions in patients with RLS ? Nocturnal BP (blood pressure) decline has major clinical implications, and the loss of normal reduction in BP during sleep is associated with high risk of cardiovascular morbidity and mortality. The main aim of this study was to evaluate the impact of rotigotine patch treatment on validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio, and endothelial function in patients with idiopathic RLS compared to placebo.

NCT ID: NCT01494766 Completed - Clinical trials for Restless Legs Syndrome (RLS)

Efficacy of Tyrosine in Restless Legs Syndrome

Start date: January 2012
Phase: N/A
Study type: Interventional

Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter, dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is subsequently and avidly converted into dopamine. It is well known that dopamine deficiency leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine agonists and L-dopa to be effective in controlling symptoms. No studies to date have been done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in treating RLS in addition to adding another possible agent to the investigators arsenal of treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated, in increments of 750 mg every week in patients who meet the inclusion criteria for RLS. Patients' symptoms will be monitored on a weekly basis for six weeks.

NCT ID: NCT01411124 Completed - Clinical trials for Restless Legs Syndrome (RLS)

Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.

NCT ID: NCT01382901 Completed - Clinical trials for Restless Legs Syndrome (RLS)

Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

Start date: March 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)

NCT ID: NCT00748098 Completed - Clinical trials for Restless Legs Syndrome

Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

NCT ID: NCT00373542 Completed - Clinical trials for Restless Legs Syndrome

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

(CR-RLS)
Start date: October 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

NCT ID: NCT00363857 Completed - Clinical trials for Restless Legs Syndrome

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Start date: August 2003
Phase: Phase 3
Study type: Interventional

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.