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Restless Legs Syndrome clinical trials

View clinical trials related to Restless Legs Syndrome.

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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: NCT01476124 Completed - Clinical trials for Restless Legs Syndrome

Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine

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

This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn alone and in combination as well as the tolerability of morphine administered with GEn. The dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a controlled release formulation of morphine will be given. Blood samples for evaluation of gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect of co-administering both treatments will be assessed using visual analog scales for somnolence/sedation, dizziness and nausea.

NCT ID: NCT01455012 Completed - Clinical trials for Restless Legs Syndrome

Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome

ENCORE
Start date: September 2011
Phase: Phase 4
Study type: Interventional

Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS) have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been shown to effectively reduce the incidence of PLMs in patients with RLS. The current study aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal BP elevations associated with PLMs in patients with RLS.

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: NCT01386944 Completed - Clinical trials for Restless Legs Syndrome

Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation

AURORA
Start date: July 2011
Phase:
Study type: Observational

The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.

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: NCT01332318 Completed - Clinical trials for Restless Legs Syndrome

Simulated Driving Study in Restless Legs Syndrome

XP083
Start date: April 2007
Phase: Phase 2
Study type: Interventional

This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.

NCT ID: NCT01332305 Completed - Clinical trials for Restless Legs Syndrome

Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome

XP081
Start date: January 2007
Phase: Phase 2
Study type: Interventional

The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).

NCT ID: NCT01327339 Completed - Clinical trials for Restless Legs Syndrome

REQUIP RLS Post Marketing Surveillance

REQUIP RLS PMS
Start date: April 2006
Phase: N/A
Study type: Observational

post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS

NCT ID: NCT01245777 Completed - Clinical trials for Iron Deficiency Anemia

Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy

Start date: October 2009
Phase: Phase 4
Study type: Interventional

In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population. During pregnancy iron tablets are the only available safe medication but their efficacy is rather poor. It is the aim of this study to examine the efficacy, practicability and safety of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia. 20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy. - Trial with medicinal product