Phase 2 N=12 Intravenous Iron Metabolism in Restless Legs Syndrome
Restless Legs
Primary: Duration Off Treatment — 6; 3; 2; 0 participants
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Phase 3 N=306 Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
Restless Legs Syndrome
Primary: The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS)…
Phase 3 N=731 Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Idiopathic Restless Legs Syndrome
Primary: Restless Legs Syndrome (RLS) Symptom Severity — 22.30; 22.40; 22.10; 22.40 Units on a Scale
Phase 3 N=60 Bupropion and Restless Legs Syndrome
Restless Legs Syndrome
Primary: Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. — -10.4; -7.6; -10.8; -6.0 points on a scale
N/A N=133 Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)
Restless Legs Syndrome
Primary: Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale for TOMAC…
Phase 2 N=295 Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Primary: Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension…
Phase 4 N=404 Long-term Study Of Ropinirole In Restless Legs Syndrome
Restless Legs Syndrome
Primary: Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26 — -12.1; -14.2; -13.4; -15.9 points on a…
Phase 4 N=329 Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Primary: Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks — -13.7; -11.1 Scores on a scale — p=0.0077
N/A N=15 Spinal Cord Stimulation for Restless Legs Syndrome
Restless Legs Syndrome · Neuropathic Pain
Primary: Percent Change MSNA Burst Frequency From Baseline to 60 Minutes — -29; -24 Percent change MSNA burst frequency
Phase 2 N=45 Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
Restless Legs Syndrome (RLS)
Primary: International Restless Legs Syndrome (IRLS) Total Score — -8.9; -4.0 Scores on a scale
Phase 2 N=10 Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Restless Legs Syndrome · Augmentation
Primary: Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period — 20.6; 21.6; 16; 18.8 score on a scale
Phase 3 N=85 Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Restless Legs Syndrome
Primary: Wake After Sleep Onset (WASO) — 51.50; 78.42; 78.60 minutes — p=<0.0001
Phase 2 N=6 Botulinum Toxin to Treat Restless Legs Syndrome
Restless Legs Syndrome
Primary: Change in Restless Legs Syndrome Rating Scale — -5.0; -1.0; -2.7; -5.0 RLS Rating Score
Phase 2 N=21 Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Restless Legs Syndrome
Primary: Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale — -2.4; -14.3; -16.0 units on a scale
Phase 3 N=284 Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
Idiopathic Restless Legs Syndrome
Primary: International Restless Legs Syndrome Rating Scale (IRLS) Total Score — -11.6; -14.3; -14.6 Scores on a scale
Phase 2 N=24 Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
Restless Legs Syndrome
Primary: Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2) — 676.86 L/h (liter per hour)
N/A N=20 Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction
Restless Legs Syndrome
Primary: Percentage of Subjects Without a Clinically Significant Increase in RLS Symptoms During the First Phase Involving an Opioid Dose Reduction of >= 20% Relative to…
Phase 3 N=325 XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
Restless Legs Syndrome
Primary: Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) — -9.8; -13.0 scores on a scale — p=0.0015
N/A N=571 Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Restless Legs Syndrome
Primary: Incidence of Drug-related Adverse Events — 76 participants
Phase 2 N=93 Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)
Restless Legs Syndrome · Iron Deficiency Anemia
Primary: Change From Baseline in the Restless Legs Syndrome Rating Scale — -14.0000; -9.7353 units on a scale — p=0.2742
Phase 3 N=30 A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
Restless Legs Syndrome · End-Stage Renal Disease
Primary: Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) — 1.16; 0.51 ratio — p=0.0232
Phase 3 N=136 Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
Restless Legs Syndrome · Restless Legs Syndrome (RLS)
Primary: Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward…
N/A N=103 Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
Restless Legs Syndrome
Primary: Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment…
N/A N=8 Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation
Restless Legs Syndrome · Willis-Ekbom Disease
Primary: Change in International Restless Legs Syndrome Rating Scale (IRLS) — 19.5 score on a scale — p=0.0396
N/A N=1,504 Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Primary: Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 — -14.48 Scores on scale
Phase 2 N=130 Simulated Driving Study in Restless Legs Syndrome
Restless Legs Syndrome
Primary: Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax) — -0.10; 0.15; 0.15; 0.16 feet
Phase 3 N=150 Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Primary: Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score — -15.46; -15.19 units on a scale — p=0.8451
Phase 2 N=230 A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
Idiopathic Restless Legs Syndrome
Primary: Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period — -9.8; -10.7; -14.4…
N/A N=549 Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
Restless Legs Syndrome
Primary: Frequency Analysis for Baseline Pattern of RLS Symptoms — 0.7; 2.4; 19.3; 18.1 percentage of participants
N/A N=687 Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
Idiopathic Restless Legs Syndrome
Primary: Severity of Restless Legs Syndrome (RLS) at Bedtime — -2.2; 5.2 units on a scale