Clinical Trial Search

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…

Primary: Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 — 15.8; 9.2; 5.1; 6.2 units on a scale

Primary: Change of Symptom Inner Restlessness (Pre - Post) — 137; 3; 6 participants

Primary: Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. — -10.4; -7.6; -10.8; -6.0 points on a scale

Primary: Severity of Restless Legs Syndrome (RLS) at Bedtime — -2.2; 5.2 units on a scale

Primary: Duration Off Treatment — 6; 3; 2; 0 participants

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…

Primary: Functional Magnetic Resonance Imaging (fMRI) Task Data: BOLD Activation Changes Within Amygdala During Negative Faces in the Hariri Face Matching Task Between Placebo…

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…

Primary: Percent Change MSNA Burst Frequency From Baseline to 60 Minutes — -29; -24 Percent change MSNA burst frequency

Primary: Change in International Restless Legs Syndrome Rating Scale (IRLS) — 19.5 score on a scale — p=0.0396

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

Primary: Change in Restless Legs Syndrome Rating Scale — -5.0; -1.0; -2.7; -5.0 RLS Rating Score

Primary: Change Scores for Criteria D Items on the CAPS Structured Clinical Interview — -1.20; -6.27 units on a scale — p=.27

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

Primary: Change in Augmentation Severity From Day 0 to Day 90 — 6.5; 0 score on a scale — p=0.0131

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…

Primary: Wake After Sleep Onset (WASO) — 51.50; 78.42; 78.60 minutes — p=<0.0001

Primary: The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score — -12.50; -12.54; -11.48; -9.93 units on a scale…

Primary: Sympathetic Baroreflex Sensitivity (BRS) Unit — -2.1; -4.3 bursts per 100 heart beats per mm Hg

Primary: Change in Worry Severity From Baseline to Post-intervention as Measured by the Penn State Worry Questionnaire (PSWQ) — 62.43; 6.19 units on a scale (PSWQ) — p=<0.005

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

Primary: International Restless Legs Syndrome Rating Scale (IRLS) Total Score — -11.6; -14.3; -14.6 Scores on a scale

Primary: Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces — .1489; .1074; .0119; .1404 Percent signal change in brain acitivity

Primary: Change in Anxiety Symptoms — 17.95; 26.2 score on a scale

Primary: Frequency Analysis for Baseline Pattern of RLS Symptoms — 0.7; 2.4; 19.3; 18.1 percentage of participants

Primary: Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 — -7.73; -11.83; -11.76…

Primary: International Restless Legs Syndrome (IRLS) Total Score — -8.9; -4.0 Scores on a scale

Primary: Dementia Cognitive Fluctuations Scale — 11.75; 8.33 score on a scale — p=<0.001

Primary: Change From Baseline in the Mean HAM-A Score at 12 Weeks of Treatment: 1. Group 1 (Tenoten®, 4 Tablets a Day); 2. Group 3 (Tenoten®, 8 Tablets a Day). — 18.81; 18.38…