Clinical Trial Search

Primary: Sialorrhea Visual Analogue Scale (VAS) — -0.55; -1.08; -1.53; -0.81 cm on VAS — p=0.6

Primary: Objectively Measured Salivary Weight — -0.07; -0.68 gm

Primary: Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection — -2.1; -3.3; -3.5; -1.3 points on a scale

Primary: Saliva Secreted Rate — -6.508; -34.512; 83.695; 7.414 percentage of change from baseline

Primary: Oropharyngeal Swallowing Score — 22.15; 21.93 Scores on a scale

Primary: Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) — -0.37; -0.36; -0.07 g/minute — p=<0.0001

Primary: Change in Voluntary Cough Peak Flow — 0.17; 0.51 l/s

Primary: Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 — 30.4; 33.2 percentage of subjects

Primary: Change in Time-to-laryngeal-vestibule-closure Thin Liquids — 0 milliseconds

Primary: Changes in Gait Velocity — 1.10; 1.15 m/s

Primary: Velocity in Gait — 1.2; 1.2; 1.2; .8 meter per second — p=.05

Primary: Change From Baseline to Endpoint of 12 Weeks in the 3-day Average of Awake Time Per Day Spent in the "Off" State — -0.4; -1.3; -1.6; -1.7 hours/day — p=0.753

Primary: Number of Micturations Per 24 Hour Period — 8.78; 9.19; 8.00; 8.94 Number of micturations per 24 hours — p=0.53

Primary: Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 — -0.07; -0.14 gram per minute (g/min) — p== 0.0012

Primary: MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 — -0.04; -0.06; -0.13 gram per minute (g/min) — p== 0.004

Primary: Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) — 7; 14; 3; 2 participants

Primary: Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS) — 68; 62; 7 Participants

Primary: ICIQ-OAB Questionnaire — 5.5; 5.8 score on a scale

Primary: Distribution Volume Ratio — 2.65; 2.70; 2.96; 2.74 Distribution volume ratios — p=0.05

Primary: Change in Montreal Cognitive Assessment Total Score — 1.5; 2 units on a scale

Primary: Percentage of Participants With Reduction in Adverse Events — 94; 86; 73; 84 percentage of participants

Primary: Gastric Emptying Time — 105; 180 minutes — p=0.036

Primary: Unified Parkinson Disease Rating Scale (UPDRS). — 12; 12; 10; 10 units on a scale

Primary: L-DOPA Insensitivity — 5 Participants — p=0.00468

Primary: Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12 — 1.6; 1.9; 1.7; 1.8 hours/day

Primary: Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline — 24.13; 24.81…

Primary: Fall Frequency Per Day — 0.13; 0.25 Number Falls/Day — p=0.049

Primary: Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment. — 0 participants

Primary: Mean Peak Dyskinesia Score — 11.00; 11.42; 8.50 Score on a scale

Primary: Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis. — 3; 3; 0.26 Decibels