Clinical Trial Search

Primary: Pain at Rest Difference Score Pre-intervention and Post Intervention — 0.38; -0.74; -0.47 units on a scale

Primary: Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test — -1.8; -0.8; 0.00; -2.0 Units on a scale — p=0.008

Primary: Change in Weekly Average Pain Intensity — -2.1; -0.97; -1.67 units on a scale

Primary: Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) Among Participants Receiving DS-5565, Pregabalin, or Placebo — -1.90; -2.64; -2.04; -2.30 units on a…

Primary: Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo — -1.86; -2.47; -2.24; -2.09 units on a…

Primary: Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention) — 4.4; 4.8 score on a scale

Primary: Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo — -1.66; -1.90; -1.97; -1.93 units on a…

Primary: Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score — 40.8; 45.3; 38.0; 39.4 score on a scale — p=0.28

Primary: Pain Relief Success Rates (Phase I) — 33; 16 percentage of exposures with relief

Primary: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score — -27.8; -9.4 units on a scale

Primary: Ambulatory Pain (Higher Values Indicate Greater Pain) — 54.6; 58.9; 46.3; 62.4 units on a scale

Primary: Change in Mu-opioid Receptor Occupancy — 0.2352; .0015 Unitless: binding potential is Bmax/Kd

Primary: Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) — 1.1751; 1.13253; 1.1046; 1.17129 ratio…

Primary: Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment. — 77.2; 126.7; 81.0 pg/mL — p=< 0.01

Primary: Change in Tender Point Pain Threshold — 19.6; -3.2 units on a scale

Primary: Number of Awakenings After Sleep Onset (NAASO) — 39.5; 34.9 Awakenings — p=0.424

Primary: Fibromyalgia Impact Questionnaire — 49.9; 37.5; 39.9; 33.4 units on a scale

Primary: Brief Pain Inventory (BPI) Change — 5.2; 5.6; 4.9; 4.8 units on a scale — p=0.42

Primary: Pain Threshold at Baseline — 2.7333; 2.583 kg/cm^2

Primary: Change in FDI (Functional Disability Inventory) Scores at End of Study — 21.4; 19.2; 13.4; 17.0 units on a 0-60 scale — p=0.007

Primary: Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern) — 0.1281; 0.1190; 0.1213; 0.1345 percentage of scan time…

Primary: Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 — -2.01; -1.28 Units on a scale — p=0.0001

Primary: Composite Syndrome Responder Status — 56; 103 Syndrome Responder Participants — p=<0.001

Primary: Pitsburgh Sleep Quality Index — 8.3 score on a questionnarie

Primary: Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) — -1.90; -1.58 units on a scale…

Primary: Visual Analog Scale-Pain — 5.30; 6.80 units on a scale

Primary: Daily Self-reported Pain Severity — 41.09; 45.55 score/day — p=0.146

Primary: Recruitment as Measured by Rates of Enrollment (Aim 1) — 120; 95; 22; 2 Participants

Primary: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 — 4.37; 12.1 Score

Primary: Mean (SD) Glx/Total Creatine Levels in Dorsal Anterior Cingulate Cortex (dACC): NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. — 2.1670; 2.0550…